BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5079195 · Received September 15, 2015

    Report

    Report Number
    3003898360-2015-00644
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 8, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDG
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DERMAHOOK 1/2 HOOK (B)(4), LOT NUMBER 73E1500506 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION: (B)(4) - ALL SAMPLES PASSED VISUAL INSPECTION WITH ZERO DEFECTS. FUNCTIONAL EVALUATION: (B)(4)- FORCE TO STRETCH (200% AND 300%) ALL SAMPLES PASSED. RESULTS ARE STATISTICALLY EQUIVALENT TO RESULTS ACHIEVED DURING DESIGN VERIFICATION TESTING. ELONGATION AT BREAK TESTS - ALL SAMPLES PASSED. (B)(4) - FORCE TO STRETCH TESTS (200% AND 300%). ALL SAMPLES PASSED. AFTER COMPLETION OF TESTING, WE CONCLUDE THAT THE PRODUCT IS PERFORMING AS EXPECTED AND MEETS ALL DESIGN REQUIREMENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE RUBBER BANDS ARE SNAPPING. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE RUBBER BANDS ARE SNAPPING. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610161 DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG GDG TELEFLEX MEDICAL 73E1500506

    Patients

    Seq Age Sex Outcome Treatment
    1