BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAHOOK 1/2 HOOK

    MDR report key: 5005345 · Received August 14, 2015

    Report

    Report Number
    3003898360-2015-00529
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GEF
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) POUCH FROM P/N 382805 DERMAHOOK 1/2 HOOK (B)(4) WERE RECEIVED NOT USED, CLOSED IN ORIGINAL PACKAGING, LOT # 73K1400269 WAS CONFIRMED. DURING VISUAL INSPECTION IT WAS OBSERVED THAT RUBBER BANDS ARE DETERIORATED. FAILURE MODE DRY ROT REPORTED BY THE CUSTOMER WAS CONFIRMED DURING VISUAL INSPECTION. SAMPLES RECEIVED CONFIRM THE DEFECT REPORTED BY THE CUSTOMER DRY ROT. A REVIEW WAS CONDUCTED OF THE IFU AND IT WAS FOUND THAT THE CUSTOMER IS DIRECTED TO "INSPECT EACH DURAHOOK AND DERMAHOOK PRIOR TO USE, SPECIFICALLY TO ENSURE THE INTEGRITY OF THE ELASTIC BAND. IF THE ELASTIC BAND CONTAINS TEARS, SPLITS OR OTHER DAMAGE, DO NOT USE." IN ADDITION, THIS DEFECT WAS FOUND BEFORE TO USE IN THE PATIENT. THEREFORE A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. HOWEVER WE WILL CONTINUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG, LOT NUMBER 73K1400269 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER BUT THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE DERMAHOOKS ARE DRY ROTTING WHICH IS EVIDENT THROUGH THE PACKAGING. THE DEFECT WAS FOUND PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE DERMAHOOKS ARE DRY ROTTING WHICH IS EVIDENT THROUGH THE PACKAGING. THE DEFECT WAS FOUND PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539534 DERMAHOOK 1/2 HOOK GEF TELEFLEX MEDICAL 73K1400269

    Patients

    Seq Age Sex Outcome Treatment
    1