BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SKULL PERFORATOR

    MDR report key: 3925 · Received July 31, 1992

    Report

    Report Number
    3925
    Event Type
    Malfunction
    Date Received
    July 31, 1992
    Date of Event
    January 14, 1992
    Report Date
    March 5, 1992
    Manufacturer
    ACRA CUT
    Product Code
    KAT
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE ACRA CUT PERFORATOR WHICH WAS POWERED BY A CODMAN PNEUMATIC CRANITOME (PROD #26-5030) PURCHASED IN NOV 1991 FAILED TO DISONGAGE AND PLUNGED INTO THE SINUS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SKULL PERFORATOR KAT ACRA CUT 200-221 DG II 907

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other