BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELFOAM

    MDR report key: 537188 · Received June 9, 2004

    Report

    Report Number
    MW1032330
    Event Type
    Other
    Date Received
    June 9, 2004
    Date of Event
    March 22, 2004
    Report Date
    June 1, 2004
    Manufacturer
    PHARMACIA AND UPJOHN CO.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LAMINOTOMY IN 2004. GELFOAM, AN ABSORBABLE HEMOSTATIC AGENT, WAS USED DURING THE PROCEDURE. IN THE EVENING, THE PT BEGAN EXPERIENCING NUMBNESS IN THE PERINEAL AREA AND THE BUTTOCKS. THEY ALSO HAD LOSS OF BOWEL AND BLADDER CONTROL. A CT SCAN SUGGESTED THE PRESENCE OF A HEMATOMA AND REOPERATION WAS PERFORMED, HOWEVER, NO SIGNIFICANT HEMATOMA WAS FOUND AND THE GELFOAM WAS REMOVED. THE PT CONTINUED TO HAVE NUMBNESS AND LOSS OF BLADDER AND BOWEL CONTROL. THE PT WAS REFERRED TO A REHABILITATION FACILITY WITH LITTLE IMPROVEMENT. REPORT IS FILED RELATED TO FDA PUBLIC NOTIFICATION REGARDING PARALYSIS FROM ABSORBABLE HEMOSTATIC AGENT ISSUED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM ABSORBABLE GELATIN SPONGE LMF PHARMACIA AND UPJOHN CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other