**Please submit comments, concerns or suggestions to
<ocwebrequest@fda.hhs.gov>**

<table>
<colgroup>
<col style="width: 7%" />
<col style="width: 1%" />
<col style="width: 8%" />
<col style="width: 4%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 1%" />
<col style="width: 4%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 18%" />
<col style="width: 27%" />
<col style="width: 0%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="16">Please save as a different filename before filling out
this form.</td>
</tr>
<tr class="even">
<td colspan="16">HHE Version 3-1 01/12/2007</td>
</tr>
<tr class="odd">
<td colspan="16"><p>Health Hazard Evaluation []</p>
<p>or Health Risk Assessment [ ]</p>
<p>Center for Devices and Radiological Health</p></td>
</tr>
<tr class="even">
<td colspan="2">Date:</td>
<td colspan="2">     </td>
<td colspan="2">RES #:</td>
<td colspan="7">     </td>
<td>Safety Officer:</td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="16">I. Product Data</td>
</tr>
<tr class="even">
<td colspan="3">Panel Code:</td>
<td colspan="2">     </td>
<td colspan="4" rowspan="2">Device Name:</td>
<td colspan="7" rowspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="3">Product Code:</td>
<td colspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2">Model:</td>
<td colspan="3">     </td>
<td colspan="6">Lot/Serial Numbers:</td>
<td colspan="4">     </td>
<td></td>
</tr>
<tr class="odd">
<td colspan="16"><p>Marketing Status (Include 510(K) Or PMA Number,
Specify If Class I Exempt From 510(K) :</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="8">Total Number Of Devices In Distribution:</td>
<td colspan="8">     </td>
</tr>
<tr class="odd">
<td>U.S.:</td>
<td colspan="6">     </td>
<td colspan="5">Foreign:</td>
<td colspan="4">     </td>
</tr>
<tr class="even">
<td colspan="10">Number Of Devices Subject To Recall or Review:</td>
<td colspan="6">     </td>
</tr>
<tr class="odd">
<td>U.S.:</td>
<td colspan="7">     </td>
<td colspan="4">Foreign:</td>
<td colspan="4">     </td>
</tr>
<tr class="even">
<td colspan="16"><p>Manufacturer / Recalling Firm, Address:</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="16"><p>Product Description (Include Intended Use From
Labeling):</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="16">ORACLE #      </td>
</tr>
<tr class="odd">
<td colspan="16">Class:       Recall #(s)      </td>
</tr>
</tbody>
</table>

+-------------------+--------------------------------------------------+
|                   |                                                  |
+-------------------+--------------------------------------------------+
| Health Hazard     |                                                  |
| Evaluation or     |                                                  |
| Health Risk       |                                                  |
| Assessment        |                                                  |
|                   |                                                  |
| Center for        |                                                  |
| Devices and       |                                                  |
| Radiological      |                                                  |
| Health            |                                                  |
+-------------------+--------------------------------------------------+
| Date:             | RES #:                                           |
+-------------------+--------------------------------------------------+
| II\. Problem      |                                                  |
| Definition and    |                                                  |
| Analysis          |                                                  |
+-------------------+--------------------------------------------------+
| **Reason for      |                                                  |
| Recall or Risk    |                                                  |
| Assessment**      |                                                  |
|                   |                                                  |
| -   **Description |                                                  |
|     of the        |                                                  |
|     Defect,       |                                                  |
|     Malfunction   |                                                  |
|     or Error in   |                                                  |
|     Use of the    |                                                  |
|     Device**:     |                                                  |
|                   |                                                  |
| >                 |                                                  |
|                   |                                                  |
| -   **Root Cause  |                                                  |
|     of the        |                                                  |
|     Problem (If   |                                                  |
|     Known):**     |                                                  |
|                   |                                                  |
| >                 |                                                  |
|                   |                                                  |
| -   **Factors     |                                                  |
|     That May      |                                                  |
|     Contribute to |                                                  |
|     Product Risk  |                                                  |
|     (i.e. Device  |                                                  |
|     Design,       |                                                  |
|     Manufacturing |                                                  |
|     Problems or   |                                                  |
|     User          |                                                  |
|     Error):**     |                                                  |
|                   |                                                  |
| **     **         |                                                  |
|                   |                                                  |
| -   **Design      |                                                  |
|     Factors That  |                                                  |
|     Might         |                                                  |
|     Mitigate      |                                                  |
|     Risk?**       |                                                  |
|                   |                                                  |
| **     **         |                                                  |
|                   |                                                  |
| -   **If Device   |                                                  |
|     Failure       |                                                  |
|     Occurs Is It  |                                                  |
|     Easily        |                                                  |
|     Recognized by |                                                  |
|     User**?       |                                                  |
|                   |                                                  |
| >                 |                                                  |
+-------------------+--------------------------------------------------+
| > Manufacturer's  |                                                  |
| > CAPA            |                                                  |
| > Investigation   |                                                  |
| > (If Available): |                                                  |
|                   |                                                  |
| -   Summary:      |                                                  |
|                   |                                                  |
|                   |                                                  |
|                   |                                                  |
| -   Date of       |                                                  |
|     Analysis:     |                                                  |
|                   |                                                  |
| >                 |                                                  |
|                   |                                                  |
| -   Firm's        |                                                  |
|     Estimate of   |                                                  |
|     Number of     |                                                  |
|     Devices that  |                                                  |
|     will Develop  |                                                  |
|     the Defect    |                                                  |
|     and/or Fail : |                                                  |
|                   |                                                  |
|     -   How Many  |                                                  |
|         Devices   |                                                  |
|         from the  |                                                  |
|         Affected  |                                                  |
|         Lots Are  |                                                  |
|         Expected  |                                                  |
|         to Have   |                                                  |
|         or        |                                                  |
|         Develop   |                                                  |
|         the       |                                                  |
|         Defect?   |                                                  |
|                   |                                                  |
| >                 |                                                  |
|                   |                                                  |
| -   How Many      |                                                  |
|     Devices with  |                                                  |
|     the Defect    |                                                  |
|     are Likely to |                                                  |
|     Exhibit the   |                                                  |
|     Failure Over  |                                                  |
|     the Lifetime  |                                                  |
|     of the        |                                                  |
|     Device?       |                                                  |
|                   |                                                  |
| >                 |                                                  |
|                   |                                                  |
| -   Of Those      |                                                  |
|     Devices that  |                                                  |
|     Fail, How     |                                                  |
|     Many are      |                                                  |
|     Likely to     |                                                  |
|     Cause Injury  |                                                  |
|     if Used?      |                                                  |
|                   |                                                  |
| >                 |                                                  |
|                   |                                                  |
| -   Any Comments  |                                                  |
|     on How these  |                                                  |
|     Estimates     |                                                  |
|     were Reached: |                                                  |
|                   |                                                  |
| >                 |                                                  |
|                   |                                                  |
| -   Firm's        |                                                  |
|     Conclusion    |                                                  |
|     About Health  |                                                  |
|     Risk. (Attach |                                                  |
|     a Copy of     |                                                  |
|     Firm's HHEs   |                                                  |
|     or HHAs):     |                                                  |
|                   |                                                  |
|                   |                                                  |
| -   Any FDA       |                                                  |
|     Comments:     |                                                  |
|                   |                                                  |
+-------------------+--------------------------------------------------+
| Adverse Events,   |                                                  |
| Complaints and    |                                                  |
| Problems or       |                                                  |
| Incidents that    |                                                  |
| may be Related to |                                                  |
| the Device        |                                                  |
| Defect:           |                                                  |
|                   |                                                  |
|   --------        |                                                  |
| ---- ------ ----- |                                                  |
| -- ------- ------ |                                                  |
| --------- ------- |                                                  |
|   Number          |                                                  |
|  of               |                                                  |
|              Malf |                                                  |
| unction           |                                                  |
|   C               |                                                  |
| omplaints         |                                                  |
|                   |                                                  |
|  Reports          |                                                  |
|                   |                                                  |
|                   |                                                  |
|                   |                                                  |
|                   |                                                  |
|                   |                                                  |
|                   |                                                  |
|   Injuri          |                                                  |
| es     U.S.       |                                                  |
|              Inte |                                                  |
| rnational         |                                                  |
|   R               |                                                  |
| eported           |                                                  |
|                   |                                                  |
|                   |                                                  |
|                   |                                                  |
|   Deaths          |                                                  |
|        U.S.       |                                                  |
|              Inte |                                                  |
| rnational         |                                                  |
|   R               |                                                  |
| eported           |                                                  |
|                   |                                                  |
|                   |                                                  |
|   --------        |                                                  |
| ---- ------ ----- |                                                  |
| -- ------- ------ |                                                  |
| --------- ------- |                                                  |
|                   |                                                  |
| Sources:          |                                                  |
|                   |                                                  |
|   ----------      |                                                  |
| ---- -- --------- |                                                  |
| --- -- ------- -- |                                                  |
|   Manufact        |                                                  |
| urer      Inspect |                                                  |
| ion      MDR's    |                                                  |
|                   |                                                  |
|   ----------      |                                                  |
| ---- -- --------- |                                                  |
| --- -- ------- -- |                                                  |
|                   |                                                  |
| Explanation:      |                                                  |
|                   |                                                  |
|                   |                                                  |
+-------------------+--------------------------------------------------+
| Describe the      |                                                  |
| Complaints and    |                                                  |
| Injuries Reported |                                                  |
| to Date:          |                                                  |
|                   |                                                  |
|                   |                                                  |
+-------------------+--------------------------------------------------+

<table style="width:100%;">
<colgroup>
<col style="width: 2%" />
<col style="width: 20%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 6%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 13%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 14%" />
<col style="width: 2%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="31"></td>
</tr>
<tr class="even">
<td colspan="31"><p>Health Hazard Evaluation or Health Risk
Assessment</p>
<p>Center for Devices and Radiological Health</p></td>
</tr>
<tr class="odd">
<td colspan="7">Date:      </td>
<td colspan="24">RES #:      </td>
</tr>
<tr class="even">
<td colspan="31"><p>III. Health Risks</p>
<p>TO BE COMPLETED BY MEDICAL OFFICER OR COMMITTEE</p></td>
</tr>
<tr class="odd">
<td colspan="31"><u>THE FOLLOWING ASSESSMENT IS BASED ON CURRENTLY
AVAILABLE INFORMATION. CONCLUSIONS MAY CHANGE IF ADDITIONAL INFORMATION
BECOMES AVAILABLE IN THE FUTURE.</u></td>
</tr>
<tr class="even">
<td colspan="31"></td>
</tr>
<tr class="odd">
<td colspan="31"><blockquote>
<p><strong>Immediate and Long Range Health Consequences:</strong></p>
</blockquote>
<ol type="A">
<li><p><strong>Describe the Immediate and Long Range Health Consequences
(Injuries or Illnesses) That May Result from Use of or Exposure to the
Defective Device.</strong> (<strong>Include Known Off Label
Uses</strong>)      </p></li>
<li><p><strong>Describe Any Clinical Factors That May Mitigate the
Risk:</strong>      </p></li>
<li><p><strong>What Segment of the Population is Most at Risk? (e.g.
Infants, Elderly, Pregnant Women, Critically Ill Patients,
Immunocompromised, etc.</strong>)      </p></li>
<li><p><strong>Does the Health Consequence Have Significant Public
Health Impact Beyond Users (e.g. Spread of Serious Infection to
Others)</strong>?      </p></li>
</ol></td>
</tr>
<tr class="even">
<td colspan="31"><p><strong>Assess the hazards associated with use of
the defective product</strong></p>
<p><strong>Check All that Might Occur:</strong></p></td>
</tr>
<tr class="odd">
<td colspan="3"><strong>Population at Greatest Risk</strong></td>
<td colspan="12"><strong>Overall Population Using Device</strong></td>
<td colspan="16"></td>
</tr>
<tr class="even">
<td colspan="3"></td>
<td colspan="12"></td>
<td colspan="16"></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="9"></td>
<td colspan="2"></td>
<td colspan="15">Life-threatening (death has or could occur)</td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="9"></td>
<td colspan="2"></td>
<td colspan="15">Results in permanent impairment of body function or
permanent damage to a body structure.</td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="9"></td>
<td colspan="2"></td>
<td colspan="15">Necessitates medical or surgical intervention.</td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="9"></td>
<td colspan="2"></td>
<td colspan="15">Temporary or reversible (without medical
intervention).</td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="9"></td>
<td colspan="2"></td>
<td colspan="15">Limited (transient, minor impairment or
complaints).</td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="9"></td>
<td colspan="2"></td>
<td colspan="15">No adverse health consequences.</td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="9"></td>
<td colspan="2"></td>
<td colspan="15">Hazard cannot be assessed with the data currently
available.</td>
</tr>
<tr class="even">
<td colspan="31"></td>
</tr>
<tr class="odd">
<td colspan="31"><strong>Explanation</strong>:      </td>
</tr>
<tr class="even">
<td colspan="31"><strong>Assess the Probability that Use of, or Exposure
to, Product under Recall will Cause Adverse Health
Consequences</strong></td>
</tr>
<tr class="odd">
<td colspan="6"></td>
<td colspan="17"><p><strong><u>Serious Adverse Health
Consequences</u></strong></p>
<p><strong>(Death, Life Threatening, Results in Permanent
Impairment)</strong></p></td>
<td colspan="8"><strong><u>Medically Reversible or Transient Adverse
Health Consequences</u></strong></td>
</tr>
<tr class="even">
<td colspan="6"></td>
<td colspan="9"><strong>Overall Population Using Device</strong></td>
<td colspan="8"><strong>Population at Greatest Risk</strong></td>
<td colspan="4"><strong>Overall Population Using Device</strong></td>
<td colspan="4"><strong>Population at Greatest Risk</strong></td>
</tr>
<tr class="odd">
<td colspan="6"></td>
<td colspan="9"></td>
<td colspan="8"></td>
<td colspan="4"></td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td colspan="6"><strong>Every Time</strong></td>
<td colspan="2"></td>
<td colspan="5"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="6"><strong>Reasonable Probability that Use will
Cause</strong></td>
<td colspan="2"></td>
<td colspan="5"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="6"><strong>Remote Probability that Use will
Cause</strong></td>
<td colspan="2"></td>
<td colspan="5"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="6"><strong>Not Likely that Use will Cause Any Adverse
Events</strong></td>
<td colspan="2"></td>
<td colspan="5"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="31"></td>
</tr>
<tr class="odd">
<td colspan="31">Explanation / Comments:      </td>
</tr>
<tr class="even">
<td colspan="31"></td>
</tr>
<tr class="odd">
<td colspan="10"><strong><u>Signatures</u></strong></td>
<td colspan="9"><strong><u>Date</u></strong></td>
<td colspan="12"><strong><u>Printed Name</u></strong></td>
</tr>
<tr class="even">
<td colspan="10"></td>
<td colspan="9"></td>
<td colspan="12"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="8"></td>
<td colspan="2"></td>
<td></td>
<td colspan="6">     </td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="even">
<td colspan="31"></td>
</tr>
</tbody>
</table>