BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2982992 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01899
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    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). 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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED, PAIN, EROSION, EXTRUSION, INFECTION, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. THE PATIENT UNDERWENT MESH REMOVAL IN 05/2008 IN PART BASED ON PHYSICIAN RECOMMENDATION. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 DUE TO STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT UNSPECIFIED REPAIR ON (B)(6) 2007. THE PATIENT UNDERWENT EXCISION OF MESH ON (B)(6) 2007 AND REMOVAL/REVISION IN (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF MESH EROSION ON (B)(6) 2007 AND ON (B)(6) 2007 UNDERWENT EXCISION WITH REVISION DUE TO MESH EROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86922 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3045489

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention