BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2991515 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02146
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, URINARY PROBLEMS, BOWEL PROBLEMS, AND BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-02145. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-02145. 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

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT ANTERIOR COLPORRHAPHY, AND VAGINAL EXTRAPERITONEAL COLOPEXY.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR COLPORRHAPHY AND ENTEROCELE REPAIR, VAGINAL EXTRAPERITONEAL COLPOSUSPENSION UTILIZING A POSTERIOR ELEVATE SYSTEM, INSERTION OF GRAFT FOR CORRECTION OF SUPPORT DEFECT ON (B)(6) 2015 BY (B)(6) AT (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT ANTERIOR COLPORRHAPHY, AND VAGINAL EXTRAPERITONEAL COLOPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96196 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3222384

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention