BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2880105 · Received December 19, 2012

    Report

    Report Number
    2210968-2012-08131
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2009 CONCURRENTLY WITH A HYSTEROSCOPY, DILATION AND CURETTAGE, AND A NOVASURE ABLATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2010 DUE TO EROSION OF MESH, PAIN, AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. DATE SENT TO THE FDA: 01/16/2017. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DISCOMFORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, URINARY INCONTINENCE AND BURNING.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND AN OBTURATOR SLING WAS IMPLANTED. CONCOMITANTLY THE PATIENT UNDERWENT A ENDOMETRIAL ABLATION. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2010 BY IMPLANTING SURGEON DUE TO EROSION AND PAIN.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3270027

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention