BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG

    MDR report key: 5098704 · Received September 23, 2015

    Report

    Report Number
    3003898360-2015-00663
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 2, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HAO
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT 73C1500603: PER DHR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG, LOT # 73C1500603 WAS MANUFACTURED ON 04/06/2015 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 04/09/2015. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. LOT 73C1500010: PER DHR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG, LOT # 73C1500010 WAS MANUFACTURED ON 03/04/2015 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 03/12/2015. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. LOT 73M1400048: PER DHR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG, LOT # 73M1400048 WAS MANUFACTURED ON 12/03/2014 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 12/12/2014. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. OTHER REMARKS: TWO (2) POUCHES FROM P/N 382800 DURAHOOK 1/4" HOOK 10 PKG/BX 6 HKS/PKG WERE RECEIVED NOT USED, CLOSED IN ORIGINAL PACKINGS, POUCHES RECEIVED ARE DIFFERENT LOTS. DURING VISUAL INSPECTION THE POUCHES ARE MARKED; ONE AS GOOD & OTHER AS BAD, THE POUCH THAT IS MARKED AS GOOD HAS RUBBER BANDS IN GOOD CONDITION; NONE BROKEN & THE LOT # IS 73C1500010, WHILE THE POUCH THAT IS MARKED AS BAD HAS RUBBER BANDS BROKEN & LOT # IS 73M14000048. IN ADDITION, THE NOTIFICATION REPORT IS REPORTING LOT # 73C1500603, THEREFORE; THIS LOT (73C1500603) DOES NOT MATCH WITH THE LOTS NUMBER OF SAMPLES RECEIVED. SAMPLE RECEIVED (MARKED AS BAD) CONFIRMS THE DEFECT REPORTED BY THE CUSTOMER BREAKS WHEN STRETCHED DURING VISUAL INSPECTION. 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." THEREFORE A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. HOWEVER WE WILL CONTINUE TO MONITOR TRENDING OF SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG, LOT NUMBER 73C1500603 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.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE ITEM IS DISCOLORED AND BREAKS WHEN STRETCHED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE ITEM IS DISCOLORED AND BREAKS WHEN STRETCHED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630219 DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG INSTRUMENT, SURGICAL, NON-POWERED HAO TELEFLEX MEDICAL 73C1500603

    Patients

    Seq Age Sex Outcome Treatment
    1