BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 7970076 · Received October 16, 2018

    Report

    Report Number
    2210968-2018-76567
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Report Date
    September 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 12/12/2018. ADDITIONAL SUMMARY: ONE GYNECARE TVT-O BOX AND IFU WAS RECEIVED. THE BOX WAS IDENTIFIED WITH LOT NUMBER 3929037 AND PRODUCT CODE 810081. THE PRODUCT RECEIVED WAS MANIPULATED: THE BLISTER CONTAINING THE DEVICE IS NOT PRESENT IN THE BOX. NO DEFECT WAS IDENTIFIED DURING THE PRODUCT EVALUATION. THE DEVICE ITSELF WAS NOT SENT FOR EVALUATION, THEREFORE THE PRODUCT EVALUATION IS NOT ALIGNED WITH THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION (BENT WIRE). CAUSE NOT ESTABLISHED.

    Additional Manufacturer Narrative · 1

    (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: WHAT WAS THE NAME OF THE PROCEDURE? INCONTINENCE SURGERY. HOW WAS THE PROCEDURE COMPLETED? -THEY USED A NEW TVTO. PLEASE RECONFIRM THAT THERE WAS NO PATIENT CONSEQUENCES. NO PATIENT CONSEQUENCES. PLEASE PROVIDE ANY PATIENT DEMOGRAPHICS. NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE IN 2018 FOR INCONTINENCE AND THE MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE, THE GUIDE WIRE BENDING ABNORMAL CURVE WAS FOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812806 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3929037 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1