BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAHOOK 1/4 HOOK

    MDR report key: 4952602 · Received July 30, 2015

    Report

    Report Number
    3003898360-2015-00546
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) POUCH FROM P/N 382800 DURAHOOK 1/4 HOOK (B)(4) WAS RECEIVED NOT USED , CLOSED IN ORIGINAL PACKAGING, LOT # 73M1400048 WAS CONFIRMED WITH RECEIVED SAMPLE, DURING VISUAL INSPECTION COMPONENTS LOOKED WELL ASSEMBLED, RUBBER BANDS DID NOT APPEAR TO HAVE DAMAGE. FUNCTIONAL INSPECTION: POUCH WAS OPENED TO REVIEW THE RUBBER BANDS CONDITIONS (UNDAMAGED), THEN RUBBER BANDS WERE FASTENED TO A PAPERBOARD, AFTER RUBBER BANDS WERE STRETCHED TO FULL CAPACITY , NO QUALITY ISSUES WERE FOUND DURING FUNCTIONAL TESTING (RUBBER BANDS WERE NOT BROKEN), THEREFORE FAILURE MODE DRY ROT REPORTED BY CUSTOMER WAS NOT ABLE TO BE DUPLICATED. SAMPLE RECEIVED DID NOT CONFIRM THE DEFECT REPORTED BY THE CUSTOMER "DRY ROT." A FUNCTIONAL INSPECTION WAS PERFORMED AND THE DEVICE WORKED PROPERLY; NOT BROKEN. THEREFORE, A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. HOWEVER, WE WILL CONTINUE TO MONITOR TRENDING OF SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DURAHOOK 1/4 HOOK 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.

    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
    498818 DURAHOOK 1/4 HOOK GDG TELEFLEX MEDICAL 73M1400048

    Patients

    Seq Age Sex Outcome Treatment
    1