BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3042817 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03647
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 9, 2011
    Report Date
    March 19, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION : USER ERROR CAUSED THE EVENT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2011 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. CONCOMITANTLY, THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY. IN 2013, THE PATIENT HAD AN XRAY OF THE PELVIS TAKEN FOR OTHER MEDICAL PURPOSES AND A ZIPPER LIKE FOREIGN BODY PROJECTING OVER THE INFERIOR PUBIC RAMUS ON THE LEFT WAS SEEN. THE SURGEON REPORTED THAT IT WAS A RETAINED SURGICAL OBJECT FROM THE SLING INSERTION. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2013 FOR A WIDE RADICAL LOCAL EXCISION OF THE LEFT VULVA AND AN EXCISION OF THE SUBURETHRAL MESH WITH REMOVAL OF THE RETAINED SURGICAL OBJECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147201 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3564636

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention