BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASTIBELL

    MDR report key: 38733 · Received September 18, 1996

    Report

    Report Number
    1480288-1996-00001
    Event Type
    Injury
    Date Received
    September 18, 1996
    Date of Event
    August 28, 1995
    Report Date
    July 23, 1996
    Manufacturer
    HOLLISTER, INC.
    Product Code
    FHG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 2 YR. OLD MALE HAD CIRCUMCISION, DUE TO BALANITIS WITH CONTRACTURE OF FORESKIN, USING A BELL MANUFACTURED BY CO. PT SEEN IN ER 5 DAYS LATER WITH PAIN, PENILE SWELLING, DYSURIA, HEMATURIA TREATED WITH ANTIBIOTIC AND PAIN MED. SEEN AGAIN IN ER ON 9/4/95, RING FELL OFF ON 9/3/95, HAS INCREASED SWELLING OF PENIS FORESKIN, PAIN ON URINATION, BROWN CRUSTING AND BRIGHT RED ERYTHEMA. TOLD TO CONTINUE ANTIBIOTIC, USE ICE BAGS. PT CONTINUED TO HAVE PAIN, SEEN IN FOLLOWUP BY SEVERAL PEDIATRIC AND UROLOGIC SPECIALISTS. MOTHER STATES PT HAS SIGNIFICANT EXCESS SKIN HANGING DOWN AS A RESULT OF THE ACUTE SWELLING, STATES PHYSICIAN HAS SAID THE CHILD MAY BE STERILE, MUST WAIT UNTIL CHILD REACHES PUBERTY TO DETERMINE; MAY ALSO NEED PLASTIC/COSMETIC SURGERY. PT IS NOW VERY FRIGHTENED OF DOCTORS/HOSPITALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASTIBELL FOR CIRCUMCISIONS FHG HOLLISTER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Other| R| S