BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT-ABBREVO MINI LCM

    MDR report key: 8067598 · Received November 13, 2018

    Report

    Report Number
    2210968-2018-77154
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 23, 2018
    Report Date
    October 24, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062368
    PMA / PMN Number
    K100936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 12/27/2018. ADDITIONAL RECEIVED FOR EVALUATION WAS ONE GYNECARE TVT ABBREVO DEVICE FROM LOT 3932673 (THE LID OF THE BLISTER CONTAINING THE LOT NUMBER, IMPLANT ASSEMBLY (MESH, GUIDES AND NEEDLES), PLACEMENT LOOP, AND THE WINGED GUIDE). THE DEVICE RECEIVED WAS MANIPULATED AND ORGANIC SUBSTANCES ARE VISIBLE ON THE DEVICE. THE DEFECT SEEN DURING THE PRODUCT EVALUATION IS ALIGNED WITH THE DEFECT DESCRIBED. THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 1

    PC-(B)(4). THE REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED ONE INTRODUCER, BENT. - PLEASE CLARIFY, IS THE INTRODUCER THAT REPORTEDLY BENT THE WHITE PLASTIC SHEATH THAT COVERS THE STAINLESS STEEL HELICAL PASSER? - UNK, DEVICE WILL RETURN FOR ANALYSIS. THIS WILL CLARIFY SOME THINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2018 AND THE MESH WAS IMPLANTED. DURING THE PROCEDURE, IT WAS DIFFICULT TO GO THROUGH THE FORAMEN AND GO FORWARD WITH ONE INTRODUCER. IT BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904695 GYNECARE TVT-ABBREVO MINI LCM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3932673 10705031062368

    Patients

    Seq Age Sex Outcome Treatment
    1