BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 71645 · Received February 21, 1997

    Report

    Report Number
    1810189-1997-00005
    Event Type
    Malfunction
    Date Received
    February 21, 1997
    Report Date
    January 23, 1997
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM AN ENT PHYSICIAN ASKING IF THERE HAD BEEN A FORMULATION CHANGE OF THE SPONGE. HE HAD BEEN USING THE PRODUCT FOR THE PAST FIFTEEN YRS FOR TYMPANIC MEMBRANE GRAFTING WITH NO PROBLEMS. HE APPLIES THE SPONGE DURING THE PROCEDURE AND THEN REMOVES IT 1-2 WEEKS LATER. HE HAD ALWAYS BEEN ABLE TO VACUUM OUT THE SPONGE EASILY, HOWEVER, IN THE PAST FEW MONTHS, HE HAD NOTICED AT THE TIME OF REMOVAL OF THE SPONGE, THAT IT IS DENSE AND ADHERED TO THE MIDDLE EAR TISSUE WHICH REQUIRES SCRAPING TO REMOVE. THIS RESULTED IN DISCOMFORT TO THE PT AND PROLONGED THE USE OF ANTIBIOTIC EAR DROPS. HE REPORTED FOUR PTS OF HIS AND TWO PTS IN WHICH HIS PARTNER NOTED THE SAME PROBLEM. ACCORDING TO CO'S QUALITY ASSURANCE, THERE HAS BEEN NO FORMULATION CHANGE IN THE PRODUCT. A DOWNWARD TREND IN THE DIGESTIBILITY OF THE PRODUCT HAS BEEN SEEN, HOWEVER, THIS IS WELL WITHIN PRODUCT SPECIFICATIONS FOR THE PRODUCT. ADD'L INFO IS BEING SOUGHT FOR EACH PT SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM STERILE SPONGE Implant ABSORBABLE GELATIN SPONGE LMF PHARMACIA & UPJOHN CO. SIZE 12X7 61 AHF

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention