BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAHOOK 1/4 HOOK

    MDR report key: 4759417 · Received May 7, 2015

    Report

    Report Number
    3003898360-2015-00358
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    February 10, 2015
    Report Date
    April 10, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HAO
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY REVIEW FOR THE PRODUCT DURAHOOK 1/4 HOOKS 10 PKG/BX 6 HKS/PKG, LOT # 01B1400057 DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. SAMPLE FROM P/N 382800 DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG WAS RECEIVED OPENED WITHOUT ORIGINAL PACKAGING, LOT NUMBER WAS NOT CONFIRMED. THE VISUAL INSPECTION REVEALED THAT THE RUBBER BANDS ARE BROKEN. THE FAILURE MODE OF BREAKING EASILY AS REPORTED BY THE CUSTOMER WAS CONFIRMED; HOWEVER, THE ROOT CAUSE IS CONSIDERED UNKNOWN BECAUSE THE SAMPLE WAS RECEIVED WITHOUT PACKAGING (LOOSE IN A BAG). A REVIEW WAS CONDUCTED OF THE IFU AND IT WAS FOUND THE CUSTOMER IS DIRECTED TO "INSPECT EACH DURAHOOK AND DERMAHOOK PRIOR TO USE, SPECIFICALLY, ENSURE THE INTEGRITY OF THE ELASTIC BAND. IF THE ELASTIC BAND CONTAINS TEARS, SPLITS OR OTHER DAMAGE, DO NOT USE." THE MFR WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE DURA HOOKS ARE BREAKING EASILY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300111 DURAHOOK 1/4 HOOK ELASTIC RETRACTORS HAO TELEFLEX MEDICAL 01B1400057

    Patients

    Seq Age Sex Outcome Treatment
    1