BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLISTER

    MDR report key: 1832175 · Received September 4, 2010

    Report

    Report Number
    MW5017345
    Event Type
    Malfunction
    Date Received
    September 4, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 4, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    EXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HOLLISTER NEW IMAGE OSTOMY POUCH WITH LOCK AND ROLL SEAL -MODEL 18182-. DESPITE FOLLOWING DIRECTIONS FOR USE, I HAVE REPEATEDLY EXPERIENCED SERIOUS LEAKS. THIS HAS BEEN AN ONGOING ISSUE FOR MORE THAN 1 YEAR, THROUGH MULTIPLE LOTS. I HAVE REPORTED THESE ISSUES TO HOLLISTER, INC. LEAKS OCCURRED IN THE FOLLOWING LOCATIONS: THROUGH AND AROUND THE CHARCOAL FILTER. JUNCTION OF PLASTIC BAG AND PLASTIC LOCKING MECHANISM -WHICH ATTACHES TO BARRIER PIECE-. THROUGH THE NECK/TAIL -LOCK AND ROLL MECHANISM-. DESIGN DOES NOT CONTAIN SEMI-LIQUID STOOL AS INTENDED. DATES OF USE: (B)(6) 2007 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: OSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER NEW IMAGE EXB HOLLISTER, INC. 18182 9K112

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR