BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3072460 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04274
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY AND STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT A URETHROLYSIS ON (B)(6) 2008 FOR BILATERAL OBSTRUCTION AND POSSIBILITY OF NONRESOLVING URGENCY AND FREQUENCY. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH TAKE-DOWN ON (B)(6) 2009 AND A MONARCH MESH WAS IMPLANTED FOR STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 DUE TO INCOMPLETE EMPTYING AND MESH EXPOSURE. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON (B)(6) 2009 PATIENT HAD A CONCURRENT PROCEDURE. THE PATIENT HAD MONARC SUBFASCIAL HAMMOCK BY AMS FOR STRESS URINARY INCONTINENCE AND A REMOVAL OF MESH BECAUSE OF RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. 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
    174344 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3135653

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention