BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIAS CUT - STOCKINETE

    MDR report key: 21554 · Received April 10, 1995

    Report

    Report Number
    21554
    Event Type
    Injury
    Date Received
    April 10, 1995
    Date of Event
    February 24, 1995
    Report Date
    April 5, 1995
    Manufacturer
    ANAGO BIAS CUT STOCKINET
    Product Code
    DWL
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED COMPLICATIONS WHICH REQUIRED AMPUTATION FOLLOWING A SKIN GRAFTING PROCEDURE. THE PT'S LEG WAS DRESSED WITH BIAS CUT STOCKINETE WHICH HAD A VERY OFFENSIVE ODOR. THE MFR HAD BEEN NOTIFIED ABOUT THE ODOR AND INDICATED IT WAS BECAUSE THERE WERE SO MANY BUGS IN THE COTTON AND 2 STERILIZATIONS WERE NECESSARY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIAS CUT - STOCKINETE BIAS CUT - STOCKINETE DWL ANAGO BIAS CUT STOCKINET NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention