BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 9597207 · Received January 16, 2020

    Report

    Report Number
    2210968-2020-00421
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 7, 2019
    Report Date
    December 22, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 02/19/2020. ADDITIONAL INFORMATION: H6. ADDITIONAL H-3 SUMMARY: TWO PICTURES WERE SHOWING ONE MESH FOR EVALUATION. THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3933940 AND PRODUCT CODE 810081. THE MESH OBSERVED ON THE PICTURE WAS MANIPULATED AND USED. AN IMPORTANT QUANTITY OF BLOOD IS PRESENT ON THE MESH. DURING THE SURGERY, THE MESH WAS USED, MANIPULATED AND STRETCHED. WE CAN SEE DAMAGES ON THE MESH. THE MESH IS STRETCHED, FRAYED. STAIN AND ORGANIC SUBSTANCES ARE ON THE MESH AND MESH PARTICLES ARE OBSERVED AROUND THE MESH. PARTICLES OF BLUE MESH ARE VISIBLE IN DUE TO MANIPULATIONS AND THE CUTTING METHOD OF MESH (MANUAL CUT). PARTICLES OF MESH ARE ACCEPTABLE IN THE PACKAGING. THE DEFECT SEEN DURING THE PICTURE EVALUATION IS ALIGNED WITH THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION ( DAMAGED MESH).THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT DUE TO EXTERNAL CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3933940 AND PRODUCT CODE 810081. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING SURGERY ON (B)(6) 2019 AND THE MESH WAS IMPLANTED. THERE WAS NO ABNORMALITY BEFORE THE USE OF THE DEVICE. DURING THE USE, WHEN THE PLASTIC SHELL WAS TAKEN OUT, ONE SIDE OF THE MESH SHOWED DEBRIS FALLING OFF, AND SOME WERE IN POWDER. IT WAS ALSO NOTED THAT THE TAPE ON ONE SIDE IS MUCH NARROWER THAN THE NORMAL TAPE ON THE OTHER. THE MESH HAS BEEN IMPLANTED AND THE PATIENT WAS DISCHARGED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58728 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3933940 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1