BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM THREADED GUIDE WIRE 230MM

    MDR report key: 3017903 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-01551
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    LRN
    PMA / PMN Number
    PREAMENDMENT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: JDW. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. D1: THE BRAND NAME WAS CORRECTED FROM SYNTHES GUIDEWIRE TO 2.0MM THREADED GUIDE WIRE 230MM. THE USER FACILITY REPORTED THE MODEL NUMBER AS 29.265. THE CORRECT CATALOG NUMBER (NOT MODEL NUMBER) SHOULD BE 292.65.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS.(B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH#: (B)(4) WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113762 2.0MM THREADED GUIDE WIRE 230MM LRN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1