BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3113796 · Received May 15, 2013

    Report

    Report Number
    2210968-2013-05583
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: USER ERROR CAUSED THE EVENT. THE SURGEON INADVERTENTLY PULLED OUT THE MESH TAPE BEFORE THE SHEATHS WERE REMOVED. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON INADVERTENTLY PULLED OUT THE MESH TAPE BEFORE SHE HAD REMOVED THE SHEATHS. THE SURGEON STATED THIS WAS A USER ERROR. THE SHEATH WAS NOT REMOVED WHEN THE TAPE WAS CUT AND THE SHEATH SLIPPED BENEATH THE SKIN. THE SURGEON TRIED TO REMOVE THE SHEATHS BUT WAS ONLY PARTIALLY SUCCESSFUL AND BELIEVED THAT THERE WAS ABOUT A 6CM PIECE LEFT IN THE PATIENT ON ONE SIDE. THE SURGEON DECIDED THAT LEAVING THE SHEATH WOULD BE LESS DAMAGING THAN ATTEMPTING TO LOOK FOR IT AND REMOVE. THE SLING WAS REMOVED AND ANOTHER LIKE DEVICE WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214774 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention