BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2973260 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01497
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-01500. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.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). IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2009 BY DR. (B)(6) DUE AT (B)(6) MEDICAL CENTER. IT WAS REPORTED THAT PATIENT UNDERWENT HARVEST OF RECTUS FASCIA, RECTUS FASCIA SLING, EXCISION OF MESH ANTERIOR AND POSTERIOR WALL, MIDURETHRAL SLING TAKEDOWN, CYSTOSCOPY, ANTERIOR REPAIR AND POSTERIOR REPAIR ON (B)(6) 2014 BY DR. (B)(6) DUE TO DYSPAREUNIA, VAGINAL SCARRING, BLADDER DYSFUNCTION AND STRESS INCONTINENCE AT (B)(6) HOSPITAL. IT WAS REPORTED THAT PATIENT UNDERWENT PUBOVAGINAL SLING (ISTOP) ON (B)(6) 2008 BY DR. (B)(6) DUE TO STRESS URINARY INCONTINENCE AT (B)(6) HOSPITAL.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/28/2017. PATIENT CODES: (B)(4) CYSTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CYSTOCELE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT CODES: (B)(4) ¿ VAGINAL DISCHARGE ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL DISCHARGE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL CONSTRICTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75754 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3101579

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention