BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEROCEL SURGIAL PRODUCTS

    MDR report key: 317366 · Received February 13, 2001

    Report

    Report Number
    MW1021150
    Event Type
    Injury
    Date Received
    February 13, 2001
    Date of Event
    September 27, 2000
    Report Date
    February 1, 2001
    Manufacturer
    MEROCEL SURGICAL PRODUCTS
    Product Code
    FRL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD LIPOSUCTION OF ABDOMEN AND BILATERAL INNER THIGHS (TUMESCENT METHOD) MINIMAL HEME IN EFFLUENT, I.E. ON ENTIRELY UNCOMPLICATED PROCEDURE. USUALLY AN ABSORBENT COTTON DRESSING (ABO) IN PLACED AGAINST THE SKIN UNDER COMPRESSIVE GARMENT A FREE SAMPLE OF A GAMMA IRRADIATED ABSORBENT POLYURETHANE FOAM DRESSING WAS GIVEN TO THE SURGICAL CENTER. DR AGREED TO TRY IT. IT SEEMED SOFT AND ABSORBENT. SOME WAS PUT OVER THE ABDOMEN. SOME WAS PLACED OVER EACH INNER THIGH. THE ABDOMINAL DRESSING STAYED DRY THE INNER THIGH DRESSINGS GOT WET FROM BLOODY EFFLUENT. THE ABDOMINAL DRESSING WAS USED 8 HRS LATER, THE INNER THIGH DRESSINGS WERE DISCARDED AT 8 HRS. THE SKIN WAS VERY RED AND ALSO MODERATELY BRUISED. 24 HRS LATER ALL THE EPIDERMIS CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5599 MEROCEL SURGIAL PRODUCTS TAB LARGE SQUARE TUMESCENT ABSORBENT BANDAGE FRL MEROCEL SURGICAL PRODUCTS * 10003

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R