BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M RED DOT

    MDR report key: 519940 · Received March 26, 2004

    Report

    Report Number
    MW1031675
    Event Type
    Other
    Date Received
    March 26, 2004
    Date of Event
    March 15, 2004
    Report Date
    March 25, 2004
    Manufacturer
    3M HEALTHCARE
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/7/04: ON FURTHER EXAMINATION OF VOLUNTARY REPORT #MW1031675, IT APPEARS THAT 3M RECEIVED THIS SAME PRODUCT COMPLAINT FROM A HEALTH PROFESSIONAL AT THE SAME HEALTH FACILITY. THE HEALTH PROFESSIONAL REPORTED TO 3M THAT THE COMPLAINT CONCERNED 3M'S RED DOT RESTING EKG ELECTRODES, CATALOG NUMBER 2360, BUT NO SPECIFIC LOT NUMBER WAS PROVIDED TO 3M. THE REPORTER OF THIS COMPLAINT/EVENT DID NOT RETURN THE DEVICE TO 3M FOR EVALUATION AND AS NOTED ABOVE, DID NOT PROVIDE A LOT SPECIFIC NUMBERS; THEREFORE, 3M WAS NOT ABLE TO PERFORM ANY LOT SPECIFIC FAILURE ANALYSIS OR LOT SPECIFIC LAB TESTING. HOWEVER, 3M REVIEWED THE COMPLAINT HISTORY FOR THIS PRODUCT. WHILE THERE IS NO INDICATION OF A TREND IN THIS TYPE OF COMPLAINT (SKIN IRRITATION), 3M COMMITS TO MONITORING THIS PRODUCT FOR ANY FUTURE SIMILAR COMPLAINTS AND TRENDS AND TO TAKE APPROPRIATE ACTION AS NECESSARY. THIS COMPLAINT WAS RECEIVED BY 3M COMPANY ON MARCH 23, 2004. THE 3M DID NOT REPORT 3M COMPLAINT AS A MFR'S MEDICAL DEVICE REPORT AS 3M DOES NOT CONSIDER SKIN IRRITATION A SERIOUS INJURY REQUIRING FURTHER MEDICAL INTERVENTION TO PRECLUDE IRREVERSIBLE IMPAIRMENT OF A BODY FUNCTION OR IRREVERSIBLE DAMAGE TO A BODY STRUCTURE.

    Description of Event or Problem · 1

    THIS PT WAS ADMITTED FOR CARDIAC COMPLANTS. RESTING EKG ELECTRODE PADS WERE PLACED FOR TESTING AND REMAINED IN PLACE FOR 24 HOURS. ONE WEEK LATER, THE PT STILL HAS SIGNIFICANT SKIN IRRITATION AT ALL SITES OF THE PADS (FULL SQUARES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M RED DOT RESTING EKG ELECTRODE PADS DRX 3M HEALTHCARE * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other