BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 236693 · Received August 17, 1999

    Report

    Report Number
    1811212-1999-00001
    Event Type
    Injury
    Date Received
    August 17, 1999
    Date of Event
    October 23, 1998
    Report Date
    August 17, 1999
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ALLEGED ALLERGIC REACTION TO MASTISOL CAUSING LOSS OF SKIN AND NON-HEALING SKIN GRAFTING TO REPAIR. CLAIMANT UNDERWENT BILATERAL MASTOPEXY (BREAST LIFT) AND LEFT BREAST BIOPSY. POST-OPERATIVELY, THE WOUNDS WERE DRESSED WITH MASTISOL. WHEN SHE RETURNED FOR A FOLLOW-UP CHECK IN THREE DAYS, A SUPERFICIAL LOSS OF SKIN WAS NOTED. THIS PROGRESSED TO A SUBSTANTIAL LOSS OF SKIN OVER THE LOWER AREA OF BOTH BREASTS, REQUIRING SKIN GRAFTING TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTISOL LIQUID ADHESIVE KMF FERNDALE LABORATORIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention| S