BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLLISTER

    MDR report key: 601299 · Received May 4, 2005

    Report

    Report Number
    MW1035412
    Event Type
    Other
    Date Received
    May 4, 2005
    Date of Event
    March 15, 2005
    Report Date
    May 4, 2005
    Manufacturer
    HOLLISTER, INC.
    Product Code
    FHG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLASTIBELL CIRCUMCISION DEVICE CAUSED LACERATION TO GLANS OF PENIS AND THE DEVICE HAD TO BE REMOVED. THE DEVICE INITIALLY HAS A BELL SHAPED PIECE OF PLASTIC ON IT THAT IS SNAPPED OFF AFTER THE CIRCUMCISION IS DONE LEAVING A PLASTIC RING ON THE PENIS THAT NORMALLY FALLS OFF IN A FEW DAYS. LEFT 2 SHARP EDGES ON IT THAT CAUSED THE LACERATION. RPTR STILL HAS THE DEVICE IN A CONTAINER. OVER THE YEARS RPTR HAS HAD TO REMOVE A FEW OF THESE FOR THE SAME REASON. FIRST TIME RPTR HAS REPORTED.

    Description of Event or Problem · 1

    THE AGENCY INFORMED HOLLISTER THAT THE INITIAL REPORTER REQUESTED THAT THEIR NAME AND INFO BE HELD AS CONFIDENTIAL AND WAS NOT TO BE GIVEN TO THE MFR. AS A RESULT HOLLISTER WAS UNABLE TO INVESTIGATE THE REPORT WITH THE INITIAL REPORTER. HOLLISTER'S INVESTIGATION REGARDING REPORT # MW1035412 WAS LIMITED TO A REVIEW OF THE MFG RECORDS FOR THE IDENTIFIED LOT NUMBER. THE RESULTS OF THE LOT INVESTIGATION INDICATED THAT THE PRODUCT WAS PRODUCED PER THE APPROPRIATE PRODUCT SPECIFICATION. HOLLISTER WILL CONTINUE TO MONITOR THE PRODUCT PERFORMANCE OF THE PLASTIBELL CIRCUMCISION DEVICE FOR ADVERSE TRENDS PER HOLLISTER'S STANDARD PRODUCT MONITORING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER PLASTIBELL CIRCUMCISION DEVICE FHG HOLLISTER, INC. * 3K07

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Other