BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRASORB SPONGES, PATIENT-READY, STERILE

    MDR report key: 172629 · Received June 16, 1998

    Report

    Report Number
    1618732-1998-00141
    Event Type
    Other
    Date Received
    June 16, 1998
    Date of Event
    April 1, 1998
    Report Date
    June 3, 1998
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    EFQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS: AFTER AN OUTPATIENT PROCEDURE, THE DEVICE WAS PLACED OVER THE TROCAR SITES AND SECURED WITH AN UNIDENTIFIED BRAND OF PAPER TAPE. WITHIN 18 HOURS, REDNESS WAS NOTICED UNDER THE DEVICES. WHEN THE DEVICES WERE REMOVED THERE WERE EXACT SOLID REDNESS IMAGES OF THE DEVICES WHICH SOON DEVELOPED INTO BLISTERS. THE BLISTERS INCREASED IN SIZE, BROKE OPEN AND DRAINED SEROUS FLUID. WITHIN ONE WEEK, PT REPORTED "SEVERE URTICARIA" OVER HER ENTIRE BODY "BOTH INSIDE AND OUT." PT WAS TREATED WITH INJECTIBLE AND ORAL STEROIDS AND ANTIHISTAMINE. THE URTICARIA TOOK TWO WEEKS TO RESOLVE AND HAS LEFT SCARS ON HER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRASORB SPONGES, PATIENT-READY, STERILE SPONGE, GAUZE EFQ JOHNSON & JOHNSON MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other