BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 71058 · Received February 21, 1997

    Report

    Report Number
    1810189-1997-00001
    Event Type
    Injury
    Date Received
    February 21, 1997
    Report Date
    February 20, 1997
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM AN INFECTION CONTROL NURSE CALLING ON BEHALF OF A SURGEON FOR STERILITY INFO CONCERNING STERILE SPONGE. THE SURGEON HAD TWO PT'S WHO DEVELOPED POSTOPERATIVE WOUND INFECTIONS AT THE GRAFT SITE FOLLOWING USE WITH SPONGE. THIS PT'S GRAFT SITE WAS CULTURED AND STAPHAUREUS FOUND. THE PT WAS TAKEN BACK TO SURGERY FOR DEBRIDEMENT. THE NURSE BELIEVED IT WAS UNLIKLEY THAT THE SPONGE WAS THE CAUSE OF THE INFECTIONS BECAUSE THE STRAIN OF STAPHAUREUS WAS DIFFERENT IN BOTH PT'S. ADD'L INFO IS BEING RECEIVED SPECIFIC TO THIS PT'S REPORTED EVENT, TREATMENT AND OUTCOME AS WELL AS OTHER INFO REQUESTED ON THIS FORM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention