BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3070049 · Received April 22, 2013

    Report

    Report Number
    2210968-2013-04197
    Event Type
    Injury
    Date Received
    April 22, 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
    CO, 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

    ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH, THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT A THIRD IMPLANT, COLOPLAST: ARIS MIDURETHRAL SLING. IT WAS FURTHER REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT REMOVAL OF MESH EXPOSURE DUE TO MESH EXPOSURE IN ANTERIOR VAGINAL WALL. (B)(4) - URINARY PROBLEMS; BOWEL PROBLEMS; UNDEFINED RECURRENCE; DYSPAREUNIA; NEUROMUSCULAR PROBLEMS; MESH EXPOSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009 AND PERIGEE 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
    171432 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1283981

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention