BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOORE MEDICAL INSTANT COLD COMPRESS

    MDR report key: 806580 · Received December 21, 2006

    Report

    Report Number
    1451040-2006-00003
    Event Type
    Injury
    Date Received
    December 21, 2006
    Date of Event
    December 10, 2006
    Report Date
    December 21, 2006
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY CO., LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT WITH SCIATICA WAS MASSAGED USING VASELINE INTENSIVE CARE HEALTHY HAND LOTION TO RELIEVE PAIN ON HER RIGHT CALF, AFTER WHICH A COLD PACK APPLIED TO THE SAME AREA. THE COLD PACK WAS WRAPPED IN A PILLOW CASE BEFORE PLACING ON THE SKIN. AFTER 20-30 MINUTES, THE COLD PACK WAS REMOVED. THE AREA OF THE LEG WHERE THE COLD PACK WAS PLACED WAS HARD AND RED WHICH THEN BECAME BLACK AND BLUE. LATER THAT EVENING, THE AREA STARTED TO BLISTER. IN 2006, MORE BLISTERING WAS EVIDENT. THE NEXT DAY, THE PT WAS TAKEN TO THE HOSPITAL BURN UNIT AND THE BLISTER WAS CUT OPEN IN ORDER TO DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOORE MEDICAL INSTANT COLD COMPRESS COLD PACK IMD SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. 79451 941587

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R