BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENISCUS GRASPING FORCEP BY O'CONNOR

    MDR report key: 9471 · Received October 13, 1994

    Report

    Report Number
    1418479-1994-09042
    Event Type
    Malfunction
    Date Received
    October 13, 1994
    Report Date
    September 28, 1994
    Manufacturer
    R. WOLF, GMBH
    Product Code
    HTD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PER ADVICE FROM THE PARENT COMPANY, THEY RECEIVED, FOR INSPECTION, THE ABOVE CAPTIONED FORCEPS. ONE OF THE JAW PIECES WAS BROKEN OFF, BUT NOT INCLUDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING 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: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCUS GRASPING FORCEP BY O'CONNOR SAME HTD R. WOLF, GMBH 8403.001 E-C-P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other