BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOCLUSIVE TRANSPARENT DRESSING - MOISTURE VAPOR PERMEABLE

    MDR report key: 195572 · Received November 6, 1998

    Report

    Report Number
    1618732-1998-00221
    Event Type
    Other
    Date Received
    November 6, 1998
    Report Date
    October 8, 1998
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC
    Product Code
    MGQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS: SUSTAINED SORES ON HER BREASTS AFTER USING DRESSING. SHE WAS SUFFERING FROM A HEAT RASH AND APPLIED THE DRESSINGS TO AVOID WEARING A BRA. THE SORE WERE TREATED BY A NURSE AND HER DOCTOR. SHE WAS PRESCRIBED A COURSE OF ANTIBIOTICS TO COMBAT INFECTION AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCLUSIVE TRANSPARENT DRESSING - MOISTURE VAPOR PERMEABLE DRESSING, SURGICAL WOUND MGQ JOHNSON & JOHNSON MEDICAL, INC NA 3399N92

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other