BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 236894 · Received August 17, 1999

    Report

    Report Number
    1810189-1999-00007
    Event Type
    Injury
    Date Received
    August 17, 1999
    Date of Event
    July 14, 1999
    Report Date
    August 17, 1999
    Manufacturer
    PHARMACIA & UPJOHN, INC.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICAIN REPORTED A 17 YEAR-OLD FEMALE DEVELOPED A FACTOR V DEFICIENCY AFTER SURGERY WITH THE USE OF GELFOAM (EXACT GELFOAM PRODUCT UNKNOWN). APPROXIMATELY 7 JUL 99, SHE UNDERWENT SPINAL FUSION SURGERY AS A RESULT OF RETT SYNDROME WHERE GELFOAM WAS USED. ABOUT ONE WEEK LATER, SHE DEVELPOED HERPARIN INDUCED THROMBOCYTOPENIA AND THE HEPARIN WAS DISCONTINUED. ABOUT 14 JUL 99, SHE DEVELOPED COAGULOPATHY FACTOR V DEFICIENCY RESULTING IN GASTROINTESTINAL BLEEDING. THE EVENT WAS CONSIDERED LIFE-THREATENING AND HOSPITALIZATION WAS PROLONGED. SHE WAS ADMINISTERED FRESH FROZEN PLASMA/FACTOR V TO TREAT THE BLEEDING. DESPITE TREATMENT, HER FACTOR V VALUE WAS <1% OM 16 JUL 99. ON 22 JUL 99, HER PLATELETS WERE INCREASING. SHE GRADUALLY IMPROVED OVER TWO WEEKS AND COAGULATION VALUES WERE NORMAL. SHE HAD NO FURTHER BLEEDING PROBLEMS. THE REPORTING PHYSICIAN SPECULATED THAT THE COAGULOPATHY COULD BE DUE TO AN IMMUNOLOGICAL REACTION TO EITHER BOVINE OR PORCINE PRODUCTS. CONSEQUENTLTY, THEY COULD ONLY ATTRIBUTE THE EVENT TO GELFOAM, ALTHOUGH THEY ARE NOT SURE WHAT CAUSED THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L| R HEPARIN,| VALPROATE ACID.