BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2770609 · Received October 3, 2012

    Report

    Report Number
    2210968-2012-05996
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (B)(4). DEVICE - POSITIONING LINES LEFT BEHIND. CONCLUSION: USER ERROR CAUSED THE EVENT. THE ATTENDING PHYSICIAN DID NOT REMOVE THE SUTURE FROM THE MESH WHEN THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2012. THE SURGEON DID NOT REMOVE THE SUTURE POSITIONING LINE(S) FROM THE MESH WHEN THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PROBLEM HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other