BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3140454 · Received May 31, 2013

    Report

    Report Number
    2210968-2013-06340
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-00370. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT URINARY INCONTINENCE, RECTOCELE, CYSTOCELE, AND VAGINAL VAULT PROLAPSE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED EROSION OF THE MESH MATERIAL, BLEEDING, DYSPAREUNIA, INFECTION, BLEEDING, AND PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION, PATIENT EXPERIENCED RECURRENCE. IT WAS REPORTED THAT PATIENT UNDERWENT VAGINAL MESH EXCISION ON (B)(6) 2012 BY DR. (B)(6) AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241996 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 2936330

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention