BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6177991 · Received December 15, 2016

    Report

    Report Number
    3003898360-2016-01159
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 14, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HAO
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER DHR THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG, LOT # 73L1500657 WAS MANUFACTURED ON 11/30/2015 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON (B)(6) 2015. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME DUE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    TWO OUT OF SIX DERMAHOOKS BROKE; THE HOOKS WERE IN PLACE, BEING USED AT THE SAME TIME WHEN THEY SNAPPED. THEY WERE ATTACHED TO THE SCALP WHEN THEY BROKE. THE HOOK REMAINED IN THE SCALP; THE SURGEON HAD TO REMOVE THEM. THE OTHER PART OF THE BROKEN HOOK REMAINED ATTACHED TO THE RUBBER BAND. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    TWO OUT OF SIX DERMAHOOKS BROKE; THE HOOKS WERE IN PLACE, BEING USED AT THE SAME TIME WHEN THEY SNAPPED. THEY WERE ATTACHED TO THE SCALP WHEN THEY BROKE. THE HOOK REMAINED IN THE SCALP; THE SURGEON HAD TO REMOVE THEM. THE OTHER PART OF THE BROKEN HOOK REMAINED ATTACHED TO THE RUBBER BAND. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828314 DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG INSRTUMENT,SURGICAL,NON-POWERED HAO TELEFLEX MEDICAL 73L1500657

    Patients

    Seq Age Sex Outcome Treatment
    1