BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2980919 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01729
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON PAH
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01731 THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ENTEROCELE REPAIR AND REMOVAL OF THE PROLIFT MESH ON (B)(6) 2016 BY (B)(6) DUE TO VAGINAL MESH EXPOSURE AND PELVIC PAIN.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY DUE TO PELVIC ORGAN PROLAPSE, AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION AND RECURRENCE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DETAILS: IT WAS REPORTED THAT THE PATIENT UNDERWENT ENTEROCELE REPAIR AND REMOVAL OF THE PROLIFT MESH ON (B)(6) 2016 BY (B)(6) DUE TO VAGINAL MESH EXPOSURE AND PELVIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84272 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON PAH NA 2996354

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention