BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 6395 · Received August 31, 1993

    Report

    Report Number
    6395
    Event Type
    Injury
    Date Received
    August 31, 1993
    Date of Event
    July 22, 1993
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HGE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT IN OR TRAUMA-DISPOSABLE PERFORATOR USED TO DRILL BURR-HOLE - MALFUNCTIONED - CUT DURA. INSTRUMENT SHOULD AUTOMATICALLY STOP PRIOR TO DURA. PATIENT HAD SUTURES TO DURA - NO FURTHER INJURY.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE PERFORATOR DISPOSABLE PERFORATOR 14MM WITH HUDSON END HGE CODMAN & SHURTLEFF, INC. 26-1221 BK8093

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention