BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2900849 · Received December 12, 2012

    Report

    Report Number
    3003898360-2012-00580
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 21, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. ASSESSMENT WAS CONDUCTED AND NO CHANGES REQUIRED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE COMPLAINANT OBSERVED THAT SEVERAL OF THE ELASTIC PORTIONS OF THE DERMAHOOK ARE SIGNIFICANTLY DEGRADED PRIOR TO THE PACKAGES BEING OPENED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG DERMAHOOK GDG TELEFLEX MEDICAL 01H100211

    Patients

    Seq Age Sex Outcome Treatment
    1