BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 76851 · Received March 11, 1997

    Report

    Report Number
    1810189-1997-00009
    Event Type
    Malfunction
    Date Received
    March 11, 1997
    Date of Event
    January 21, 1997
    Report Date
    March 7, 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 AFTER FOLLOWING UP WITH MULTIPLE REPORTS IN WHICH SPONGE WAS DENSE AND IT ADHERED TO MIDDLE EAR STRUCTURES WHICH REQUIRED SCRAPING TO REMOVE. HE REPORTED AN ADD'L TWO CASES IN WHICH THE SAME PROBLEMS CONTINUE TO OCCUR. HE HAD BEEN USING SPONGE FOR THE PAST FIFTEEN YEARS FOR TYMPANIC MEMBRANE GRAFTING WITH NO PROBLEMS. HE APPLIED THE SPONGE DURING THE PROCEDURE AND 1-2 WEEKS LATER WAS ABLE TO EASILY VACUUM IT OUT. RECENTLY, AT THE TIME OF REMOVAL (SPONGE), IT IS DENSE ADHERED TO THE MIDDLE EAR REQUIRING SCRAPING TO REMOVE. IT HAS RESULTED IN DISCOMFORT TO THE PT AND PROLONGED THE USE OF ANTIBIOTIC EAR DROPS. ACCORDING TO CO QUALITY ASSURANCE, THERE HAS BEEN NO FORMULATION CHANGE WITH PRODUCTS. A DOWNWARD TREND IN THE DIGESTIBILITY OF THE PRODUCT HAS BEEN SEEN, HOWEVER, THIS IS WELL WITHIN PRODUCT SPECIFICATIONS. NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM STERILE SPONGE Implant ABSORBABLE GELATIN SPONGE LMF PHARMACIA & UPJOHN CO. 12 X 7 (SIZE) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention