BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM (ABSORBABLE GELATIN) SPONGE

    MDR report key: 1963773 · Received January 11, 2011

    Report

    Report Number
    MW5019012
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    PFIZER PHARMACIA & UPJOHN
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OPENING GELFOAM - ABSORBABLE GELATIN SPONGE-SIZE 100 IN THE OPERATING ROOM SUITE, THE OUTSIDE PAPER COVER TORN AND DID NOT PEEL OPEN CAUSING THE PRODUCT TO BE WASTED AND TRYING TO FIND ONE THAT PEELS OPEN, SO THE GELATIN SPONGE CAN BE DROPPED ON THE STERILE FIELD AND USED. WE ARE HAVING REGULAR PROBLEMS WITH THE OUTER WRAP NOT PEELING, AS IT DID BEFORE. THE OUTER WRAPS ARE TEARING THE PAPER AND NOT UNWRAPPING THE SPONGE. WASTE OF PRODUCT, TIME AND POTENTIAL CONTAMINATION RISK TO THE SURGICAL FIELD. DOSE OR AMOUNT: 100 SQ CM, ROUTE: TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM (ABSORBABLE GELATIN) SPONGE ABSORBABLE GELATIN SPONGE, 100 SQ CM LMF PFIZER PHARMACIA & UPJOHN OBAPK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other