§ 803.42 If I am an importer, what information must I submit in my individual adverse event reports? You must include the following information in your report, if the information is known or should be known to you, as described in § 803.40. These types of information correspond generally to the format of Form FDA 3500A: ( a ) Patient information (Form FDA 3500A, Block A). You must submit the following: ( 1 ) Patient name or other identifier;
( 2 ) Patient age at the time of event, or date of birth;
( 3 ) Patient gender; and
( 4 ) Patient weight.
( b ) Adverse event or product problem (Form FDA 3500A, Block B). You must submit the following: ( 1 ) Identification of adverse event or product problem;
( 2 ) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is: ( i ) A life-threatening injury or illness;
( ii ) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or
( iii ) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function;
( 3 ) Date of event;
( 4 ) Date of this report;
( 5 ) Description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event;
( 6 ) Description of relevant tests, including dates and laboratory data; and
( 7 ) Description of other relevant patient history, including preexisting medical conditions.
( c ) Device information (Form FDA 3500A, Block D). You must submit the following: ( 1 ) Brand name;
( 2 ) Product Code, if known, and Common Device Name;
( 3 ) Manufacturer name, city, and state;
( 4 ) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package;
( 5 ) Operator of the device (health professional, lay user/patient, other);
( 6 ) Date of device implantation (month, day, year), if applicable;
( 7 ) Date of device explanation (month, day, year), if applicable;
( 8 ) Whether the device is a single-use device that was reprocessed and reused on a patient (Yes, No)?
( 9 ) If the device is a single-use device that was reprocessed and reused on a patient (yes to paragraph (c)(8) of this section), the name and address of the reprocessor;
( 10 ) Whether the device was available for evaluation, and whether the device was returned to the manufacturer, and if so, the date it was returned to the manufacturer; and
( 11 ) Concomitant medical products and therapy dates. (Do not report products that were used to treat the event.)
( d ) Initial reporter information (Form FDA 3500A, Block E). You must submit the following: ( 1 ) Name, address, and telephone number of the reporter who initially provided information to the manufacturer, user facility, or distributor;
( 2 ) Whether the initial reporter is a health professional;
( 3 ) Occupation; and
( 4 ) Whether the initial reporter also sent a copy of the report to us, if known.
( e ) Importer information (Form FDA 3500A, Block F). You must submit the following: ( 1 ) An indication that this is an importer report (by marking the importer box on the form);
( 2 ) Your importer report number;
( 3 ) Your address;
( 4 ) Your contact person;
( 5 ) Your contact person's telephone number;
( 6 ) Date that you became aware of the event (month, day, year);
( 7 ) Type of report (initial or followup). If it is a followup report, you must include the report number of your initial report;
( 8 ) Date of your report (month, day, year);
( 9 ) Approximate age of device;
( 10 ) Event problem codes—patient code and device code (refer to FDA MedWatch Medical Device Reporting Code Instructions);
( 11 ) Whether a report was sent to us and the date it was sent (month, day, year);
( 12 ) Location where event occurred;
( 13 ) Whether a report was sent to the manufacturer and the date it was sent (month, day, year); and
( 14 ) Manufacturer name and address, if available.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]