BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2991589 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02118
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION DUE TO MIXED INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, RECURRENCE AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED. (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. 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 FOLLOWING INSERTION THE PATIENT EXPERIENCED MIXED URINARY INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS USED. 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 MIXED URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94914 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 2984530

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention