BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 165139 · Received April 28, 1998

    Report

    Report Number
    1810189-1998-00002
    Event Type
    Injury
    Date Received
    April 28, 1998
    Report Date
    April 28, 1998
    Manufacturer
    PHARMACIA & UPJOHN, INC.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D FROM A MAN WHO HAD PREVIOUSLY REPORTED ARACHNOIDITIS ASSOCIATED WITH METHYLPREDNISOLONE ACETATE IN 1994. HE CONTACTED PHARMACIA & UPJOHN ON 14APR98, INDICATING THAT GELFOAM HAD BEEN USED DURING A LAMINECTOMY PROCEDURE AND HE BELIEVED THAT BOTH PRODUCTS CONTRIBUTED TO THE ARACHNOIDITIS. HE WAS REQUESTING COMPENSATION CONCERNING THE GELFOAM. HE DID NOT PROVIDE ANY OTHER INFO. HE WAS INVOLVED IN A CLASS ACTION SUIT AND REC'D COMPENSATION FOR THE METHYLPREDNISOLONE ACETATE. ALTHOUGH THE SOURCE DID NOT PROVIDE SERIOUS CRITERIA, A CO PHYSICIAN DETERMINED THE EVENT TO BE MEDICALLY SERIOUS AS MEDICAL INTERVENTION OR TREATMENT WAS NECESSARY FOR THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O| R