BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2970333 · Received February 20, 2013

    Report

    Report Number
    2210968-2013-01469
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PATIENT UNDERWENT PARTIAL MESH REMOVALS ON (B)(6) 2005, (B)(6) 2005, AND (B)(6) 2006.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT PERIURETHRAL SCARRING, MIXED URINARY INCONTINENCE, AND CYSTOCELE. IT WAS ALSO REPORTED THAT AT THE TIME OF MESH IMPLANTATION THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF TRANSVAGINAL URETHROLYSIS, CYSTOCELE REPAIR, PELVICOL SUPPORT OF CYSTOCELE REPAIR, SACROSPINOUS LIGAMENT FIXATION, HARVEST OF RECTUS FASCIA, PUBOVAGINAL SLING, AND RECTUS FASCIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PERSISTENT URINARY RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND PELVICOL WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT ANOTHER GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A SLING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PERSISTENT URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73600 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1260346

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention