BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 121410 · Received September 17, 1997

    Report

    Report Number
    1810189-1997-00019
    Event Type
    Injury
    Date Received
    September 17, 1997
    Date of Event
    June 28, 1997
    Report Date
    August 22, 1997
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D FROM AN INFECTION CONTROL NURSE CALLING FOR INFO CONCERNING GELFOAM STERILE SPONGE. NURSE DESCRIBED A PT WHO UNDERWENT LEFT AND RIGHT ANTERIOR AND POSTERIOR ETHMOIDECTOMY WITH MIDDLE MEATAL ANTROSTOMY, RIGHT SPHENOIDECTOMY AND SEPTOPLASTY. GELFOAM STERILE SPONGE WAS USED TO PACK THE NASAL CAVITY FOR HEMOSTASIS. THE SURGERY WAS UNEVENTFUL. SUBSEQUENTLY, THIS PT DEVELOPED DIARRHEA, INITIALLY THOUGHT TO BE ANTIBIOTIC ASSOCIATED. HOWEVER, DURING HIS VACATION, HE DID NOT FEEL WELL AND WENT TO ANOTHER HOSP. PT WAS HOSPITALIZED WITH DIARRHEA, HYPOVOLEMIC SHOCK AND RENAL FAILURE. A DIAGNOSIS OF STAPHYLOCOCCAL TOXIC SHOCK WAS MADE AFTER CULTURES REVEALED STAPH AUREUS-TOXIC SHOCK TOXIN 1 AND STAPH AUREUS ENTEROTOXIN A. THESE CULTURES WERE VERIFIED BY THE HLTH DEPT. THIS MAN UNDERWENT ENDOSCOPIC SINUS SURGERY WITH NASAL ENDOSCOPY AND DEBRIDEMENT OF THE MAXILLARY SINUSES BILATERALLY, AND NASAL ENDOSCOPY WITH DEBRIDEMENT OF THE ETHMOID SINUSES BILATERALLY. HE WAS TREATED WITH UNASYN IV, FLAGYL IV AND DISCHARGED WITH ORAL AUGMENTIN. IT WAS ALSO REPORTED THAT HE DEVELOPED A FINE, RED RASH. IT WAS THOUGHT THAT THE GELFOAM PACKING HAD BEEN REMOVED AT THE TIME OF THE INITIAL SURGERY, HOWEVER, PRIOR TO THE SECOND SURGERY, THE PT SPONTANEOUSLY EXPELLED THE PACKING FROM THE NARES. THE PT HAD A CHRONIC INFLAMMATION OF THE SINUSES AT THE TIME OF THE FIRST SURGICAL PROCEDURE. APPROX 4-5 DAYS PRIOR TO HOSP ADMISSION, PT HAD DEVELOPED A SORE THROAT WHICH WAS QUIT SEVERE. PT WAS EXAMINED BY AN ENT PHYSICIAN WHO RECOMMENDED SOME TYPE OF IRRITATIONS AND PRESCRIBED PENICILLIN ELIXIR AT THE TIME. PT SOON DEVELOPED DIARRHEA, NAUSEA, AND VOMITING, HOWEVER, TRAVELED TO ANOTHER STATE. DURING THE DRIVE, PT CONTINUED TO HAVE REPETITIVE NAUSEA, VOMITING AND DIARRHEA. SINCE THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNK, THE DEVICE COULD NOT BE EVALUATED. NO FURTHER INFO IS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| O| R PENICILLIN (ORAL)