BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED FLEXIBLE ARM ASSEMBLY

    MDR report key: 118522 · Received September 5, 1997

    Report

    Report Number
    1030489-1997-00123
    Event Type
    Malfunction
    Date Received
    September 5, 1997
    Date of Event
    August 6, 1997
    Report Date
    August 6, 1997
    Manufacturer
    SOFAMAR DANEK MEDICAL, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FLEXIBLE ARM DISASSEMBLED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED FLEXIBLE ARM ASSEMBLY POSITIONING DEVICE HRX SOFAMAR DANEK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN