BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAF-T-SHUNT

    MDR report key: 701 · Received June 2, 1992

    Report

    Report Number
    701
    Event Type
    Death
    Date Received
    June 2, 1992
    Date of Event
    May 4, 1992
    Report Date
    May 14, 1992
    Manufacturer
    AKCESS
    Product Code
    FIQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD SCRIBNER SHUNT. LAB TECH FOUND PATIENT UNRESPONSIVE IN BED WITH BLOOD IN BED AND ON FLOOR. CODE 99 CALLED BUT UNSUCCESSFUL. USER FACILITY SUSPECTS PATIENT TAMPERED WITH "T" CONNECTOR. THE DEVICE HAD BEEN TEMPORARILY REMOVED FROM SERVICE PENDING ITS EVALUATIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.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: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-SHUNT Implant SCRIBNER SHUNT FIQ AKCESS ST-714 AN107

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death