BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAHOOK 1/4 HOOK

    MDR report key: 4952228 · Received July 30, 2015

    Report

    Report Number
    3003898360-2015-00545
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 22, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDG
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DURAHOOK 1/4 HOOKS 10 PKG/BX 6 HKS/PKG, LOT NUMBER 73M1400048 DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE DURAHOOKS ARE DRY ROTTING WHICH IS EVIDENT THROUGH THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496457 DURAHOOK 1/4 HOOK GDG TELEFLEX MEDICAL 73M1400048

    Patients

    Seq Age Sex Outcome Treatment
    1