BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972819 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01476
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    December 5, 2017
    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
    Health Professional
    N

    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

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND SECONDARY RECTOCELE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURE OF CYSTOSCOPY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/28/2017 (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT VAGINAL YEAST INFECTION AND VAGINAL DISCHARGE.

    Additional Manufacturer Narrative · 1

    PATIENT CODE: (B)(4) ¿ INCONTINENCE ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT CODES: (B)(4) - BURNING SENSATION, (B)(4) - DISCOMFORT. DETAILS: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BURNING SENSATION AND DISCOMFORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76865 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3453214

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention NI.