BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM 8X12.5

    MDR report key: 1932689 · Received December 14, 2010

    Report

    Report Number
    MW5018604
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO SURGERY NURSES, THESE DO NOT OPEN PROPERLY. THEREFORE, IT IS DIFFICULT TO MAINTAIN STERILITY. I FIRST NOTIFIED THE MFR IN (B)(6) 2010. SURGERY CALLED AGAIN LAST WEEK TO INFORM ME THAT THIS HAS BEEN AN ISSUE AGAIN FOR THE LAST TWO MONTHS. I DO NOT HAVE PT NAMES OR HISTORY. IT HAS JUST BEEN A CONSISTENT PROBLEM. DATES OF USE: LAST 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM 8X12.5 GELFOAM SIZE 100 LMF PHARMACIA & UPJOHN CO. SIZE 100 OBAPM
    2 GOLFOAM 8X12.5 GELFOAM SIZE 100 LMF PHARMACIA & UPJOHN CO. OA6K7

    Patients

    Seq Age Sex Outcome Treatment
    1 *