BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 10087859 · Received May 26, 2020

    Report

    Report Number
    2210968-2020-04108
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    March 6, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION ONE SUB-ASSEMBLY OF TVTRL, BATCH (B)(4), COMPOSED OF TWO WHITE PLASTIC NEEDLES, BLUE PROLENE MESH AND PLASTIC SHEATH. THE RECEIVED DEVICE WAS MANIPULATED AND WAS NOT IN ITS ORIGINAL BLISTER. IT WAS STRONGLY FOLDED. THE PLASTIC SHEATH ON BOTH EXTREMITIES OF THE MESH WAS RIPPED ON THE MESH'S EDGE AT THE EXACT POSITION WHERE THE MESH WAS FOLDED. THE IDENTIFIED DEFECT IS NOT LINKED TO A MANUFACTURING ISSUE. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3935246 AND PRODUCT CODE TVTRL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2020 AND MESH WAS USED. AFTER UNPACKING THE MESH, THE SURGEON NOTICED THE PROTECTIVE COVER OF THE MESH WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551871 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. TVTRL 3935246 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1