BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2983468 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01938
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH DIAGNOSTIC LAP, TOTAL HYSTERECTOMY, COLPORRHAPHY WITH ANTERIOR REPAIR DUE TO SYMPTOMATIC CYSTOCELE, PERINEAL RELAXATION, AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2009 DUE TO FAILED MID URETHRAL SLING AND RECURRENT CYSTOCELE. IT WAS REPORTED THAT IT HAD NOT ENCAPSULATED HOWEVER IT DID NOT APPEAR TO HAVE BEEN SECURED WELL ON EITHER LATERAL ATTACHMENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE MESH WAS EXPLANTED ON (B)(6) 2009 AND LYNX MESH WAS IMPLANTED AT THAT TIME. 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE MESH WAS EXPLANTED ON (B)(6) 2009 AND LYNX MESH WAS IMPLANTED AT THAT TIME. IT WAS REPORTED THAT SHE 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
    86282 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3051645

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention