BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM FILM TRANSPARENT DRESSING FRAME STYLE

    MDR report key: 1902327 · Received November 12, 2010

    Report

    Report Number
    2110898-2010-00126
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 12, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    NAD
    PMA / PMN Number
    K973036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: NO EVAL WILL BE PERFORMED. DEVICE OR LOT CODE NOT PROVIDED TO MANUFACTURER FOR EVAL. COMPLAINT TYPE WILL BE MONITORED.

    Description of Event or Problem · 1

    HEALTH CARE FACILITY CUSTOMER REPORTS THAT PT'S SKIN DEVELOPED SMALL WATER BLISTERS AND REDNESS UNDER THE DRESSING, FOLLOWING LAPAROSCOPIC SURGERY. A TOTAL OF THREE TEGADERM DRESSINGS WERE APPLIED TO PT'S ABDOMEN. PT WAS TREATED IN ER FOR SIX HOURS. IN THE ER, PT'S ABDOMEN FROM HER BREASTS TO THIGHS BECAME RED WITH HIVES AND TINY BLISTERS. THE FOLLOWING DAY, THE PT'S ABDOMEN WAS ITCHING AND ALLEGES THAT HER SKIN HAD PEELED FROM HER ABDOMEN WHERE THERE ARE RED AREAS AND PIGMENTATION CHANGES AT THE LOCATION WHERE THE TEGADERM DRESSING HAD BEEN PLACED. CUSTOMER HAS STATED THAT SHE HAS USED TEGADERM HUNDREDS OF TIMES AND HAS NEVER HAD A REACTION. HEALTH CARE FACILITY CUSTOMER HAS REPORTED THAT THE PT'S BLISTERS, ERYTHEMA, AND ITCHING HAVE IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM FILM TRANSPARENT DRESSING FRAME STYLE TEGADERM FILM TRANSPARENT DRESSING NAD 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IV FLUIDS| BENADRYL| IV STEROIDS| MEDROL PACK (TO BE TAKEN OVER A 5-DAY PERIOD)