BEUDAMED
    FDA Adverse Event Summary report: N

    OR TABLE

    MDR report key: 9602 · Received October 19, 1994

    Report

    Report Number
    9602
    Date Received
    October 19, 1994
    Date of Event
    October 7, 1994
    Report Date
    October 17, 1994
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    BWN
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TABLE EXTENSION BECAME DISLODGED FROM O/R TABLE AND TIPPED. PT SLIPPED TO END OF EXTENSION. SURGERY CANCELLED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUN-94. SERVICE PROVIDED BY: INDEPENDENT SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: USER ERROR CAUSED EVENT. 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 OR TABLE TABLE BWN AMERICAN STERILIZER CO. 2080

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Invalid Data