BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG

    MDR report key: 8612388 · Received May 15, 2019

    Report

    Report Number
    3003898360-2019-00600
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    March 19, 2019
    Report Date
    May 1, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. A VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS WAS CONDUCTED AS FOLLOWS: 125 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION P/N DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG, LOT# 73E1900056, THE SAMPLES WERE FUNCTIONALLY INSPECTED, AND ISSUE REPORTED AS RUBBER BANDS BREAKING WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. THE DEVICE HISTORY REVIEWS THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG LOT# 73K1800935 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND TO CONFIRM THE ALLEGED DEFECT. AT THIS TIME SINCE THE SAMPLE IS NOT AVAILABLE IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND TO DETERMINE THE ROOT CAUSE. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELASTIC IS BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405285 DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG INSTRUMENT, SURGICAL, NON-POWE HAO TELEFLEX MEDICAL 73K1800935

    Patients

    Seq Age Sex Outcome Treatment
    1