BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM ABSORBABLE 12-7MM

    MDR report key: 2081829 · Received May 3, 2011

    Report

    Report Number
    MW5020508
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 3, 2011
    Manufacturer
    PHARMACIA & UPJOHN CO - DIV OF PFIZ
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN OPERATING ROOM NURSE PEELS OPEN THE GELFOAM, THE PAPERS DO NOT PEEL OPEN AND THEY END UP WASTING THE PRODUCT. EXPENSIVE WASTE. POSSIBLY A BETTER PACKAGING CAN BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM ABSORBABLE 12-7MM ABSORBABLE SPONGE LMF PHARMACIA & UPJOHN CO - DIV OF PFIZ 0BCU1
    2 GELFOAM ABSORBABLE 12-7 MM ABSORBABLE SPONGE LMF PHARMACIA & UPJOHN CO - DIV OF PFIZ 0BAPS

    Patients

    Seq Age Sex Outcome Treatment
    1