BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 87418 · Received March 31, 1997

    Report

    Report Number
    1810189-1997-00018
    Event Type
    Injury
    Date Received
    March 31, 1997
    Date of Event
    December 13, 1993
    Report Date
    March 28, 1997
    Manufacturer
    PHARMACIA AND UPJOHN CO.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT WAS RECEIVED VIA THE COMMON COURT OF PLEAS OF A WOMAN WHO DEVELOPED AN INFECTION IN THE SURGICAL SITE AS A RESULT OF THE USE WITH SPONGE. MEDICAL RECORDS WERE PROVIDED. THIS IS A REPORT OF A WOMAN WHO UNDERWENT ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF HER RIGHT KNEE 12/8/93, FOLLOWING AN INJURY WHILE PLAYING VOLLEYBALL. FOUR DAYS POSTOPERATIVE, SHE HAD A FEVER (102-F), EFFUSION RIGHT KNEE, AND MILD ERYTHEMA. HER FEVER WAS ATTRIBUTED TO AN ALLERGIC SKIN RASH. ON 12/17/93, SHE WAS SEEN IN THE EMERGENCY ROOM WITH FEVER, CHILLS, FULLNESS, AND SENSITIVITY OVER THE ANTERIOR ASPECT OF THE RIGHT LEG ALONG THE AREA OF THE MEDICAL TIBIAL PLATEAU FLARE. A CELLULITIS WAS NOTED THE PROXIMAL ONE-THIRD OF THE ANTERIOR HALF OF HER LEG WHICH WAS TENDER, WARN AND BRAWNY INDURATION. SHE WAS HOSPITALIZED AND PLACED ON GENTAMICIN AND VANCOMYCIN. SHE RESPONDED QUICKLY TO ANTIBIOTIC THERAPY, HOWEVER, DEVELOPED SOME DRAINAGE FROM THE AREA OF PREVIOUS PALPABLE FLUID. SHE THEN UNDERWENT OPEN DEBRIDEMENT AND LAVAGE OF THE RIGHT KNEE ON 12/20/93. AN AREA OF SEROPURLENT FLUID AROUND SPONGE PACKING WAS FOUND, REMOVED AND CULTURED. SHE WAS LATER DISCHARGED ON ORAL KEFLEX AND NO FURTHER PROBLEMS NOTED. CASE REMAINS UNDER INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R GENERAL ANESTHESIA, LACTATED RINGERS, PERCOCET,| TORADOL, MARACAINE, XYLOCAINE WITH EPINEPHRINE