Section 22-B10416. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES

 

10416.1A user facility shall include the following information in its report, if reasonably known:

 

(a) For patient information, the user facility shall submit the following:

 

(1)The patient’s name or other identifier;

 

(2)The patient’s age at the time of event, or date of birth;

 

(3)The patient’s sex; and

 

(4)The patient’s weight;

 

(b) For an adverse event or product problem, the user facility shall submit the following:

 

(1) Identification of the adverse event or product problem;

 

(2) Outcomes attributed to the adverse event (for example, death or serious injury). An outcome is considered a serious injury if it is:

 

(A)A life-threatening injury or illness;

 

(B)A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or

 

(C)An injury or illness that requires intervention to prevent permanent impairment of a body structure or function;

 

(3)The date of the event;

 

(4) The date of report by the initial reporter;

 

(5) A description of event or problem, including a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event;

 

(6) A description of relevant tests, including dates and laboratory data; and

 

(7)A description of other relevant history, including preexisting medical conditions;

 

(c)For device information, you must submit the following:

 

(1) The brand name;

 

(2) The type of device;

 

(3) The manufacturer’s name and address;

 

(4) The operator of the device (health professional, patient, lay user, other);

 

(5) The expiration date;

 

(6) The model, catalog, serial, lot, or other identifying number;

 

(7) The date of device implantation (month, day, and year);

 

(8) The date of device expiration (month, day, and year);

 

(9) Whether the device was available for evaluation and whether the device was returned to the manufacturer; if so, the date it was returned to the manufacturer; and

 

(10) Concomitant medical products and therapy dates; 

 

(d)For initial reporter information, you must submit the following:

 

(1) Name, address, and telephone number of the reporter who initially provided information to you, or to the manufacturer 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 the Department, if known; and 

 

(e)For user facility information, you must submit the following:

 

(1) An indication that this is a user facility report (by marking the user facility box on the form);

 

(2) Your user facility number;

 

(3) Your address;

 

(4) Your contact person;

 

(5) Your contact person's telephone number;

 

(6) The date that you became aware of the event (month, day, year);

 

(7) The type of report (initial or follow-up);

 

(8)The report number of the initial report, if a follow-up report;

 

(9) The date of the report (month, day, and year);

 

(10) The approximate age of device;

 

(11) The event problem codes--patient code and device code (refer to the "MEDWATCH Medical Device Reporting Code Instructions");

 

(12) Whether a report was sent to the Department and the date it was sent (month, day, and year);

 

(13) The location where the event occurred;

 

(14) Whether the report was sent to the manufacturer and the date it was sent (month, day, year); and

 

(15) The manufacturer’s name and address, if available.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).