BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3032600 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03207
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    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.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2009 DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, BLEEDING, DYSPAREUNIA, PULLING SENSATION, URINARY URGENCY, URINARY FREQUENCY AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION DUE TO MESH EROSION ON (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2012. (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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE. ON (B)(6) 2011, THE PATIENT UNDERWENT CYSTOSCOPY AND NOTED TWO BLADDER STONES ADHERENT TO THE RIGHT LATERAL BLADDER WALL. THE PATIENT WAS TAKEN TO OPERATING ROOM ON (B)(6) 2011 AND A SMALL PIECE OF MESH WAS VISIBLE ON THE RIGHT LATERAL BLADDER WALL AFTER STONE HAD BEEN REMOVED. ON (B)(6) 2011, THE PATIENT UNDERWENT REMOVAL OF MESH MATERIAL FROM BLADDER CYSTOSCOPICALLY. THE PATIENT UNDERWENT CYSTOURETHROSCOPY AND EXCISION OF FOREIGN BODY ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND URINARY INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

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

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136620 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3308194

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention