BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE PERFORATOR 14MM WITH HUDSON END

    MDR report key: 5480 · Received April 9, 1993

    Report

    Report Number
    5480
    Event Type
    Injury
    Date Received
    April 9, 1993
    Date of Event
    March 4, 1993
    Report Date
    March 11, 1993
    Manufacturer
    CODMAN
    Product Code
    HGE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PERFORATOR JAMMED AND DID NOT STOP WHEN CRANIUM DRILLED. CAN RESULT IN A DURAL TEAR. CAUSED A DURAL TEAR AND SIGNIFICANT BLOOD LOSS TO PATIENT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PERFORATOR 14MM WITH HUDSON END PERFORATOR HGE CODMAN 26-1221 MJ8127

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention