BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2980930 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01715
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    IT WAS REPORTED THAT PATIENT UNDERWENT PUBOVAGINAL SLING WITH CADAVERIC FASCIA, CYSTOSCOPY ON (B)(6) 2001 BY DR. (B)(6) AT (B)(6) MEDICAL CENTER ((B)(6)) DUE TO SUI. (PER OPERATIVE REPORT) IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF A RECURRENT EPIGASTRIC VENTRAL INCISIONAL HERNIA WITH PARTIAL REMOVAL OF OLD MESH, VENTRIO ST HERNIA PATCH IMPLANT AND EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2012 BY DR. (B)(6) CROSS AT (B)(6) MEDICAL CENTER ((B)(6)) DUE TO RECURRENT EPIGASTRIC VENTRAL INCISIONAL HERNIA. (PER OPERATIVE REPORT).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS, DYSPAREUNIA, RECURRENCE, WORSENING INCONTINENCE, AND DISCOMFORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83643 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1295220

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention