BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2920975 · Received January 17, 2013

    Report

    Report Number
    2210968-2013-00428
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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 FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY, AND HYPERMOBILE URETHRA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT FULL INTERSTIM IMPLANTATION ON (B)(6) 2014 DUE TO URINARY URGENCY AND FREQUENCY. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, A HYPERMOBILE URETHRA, AND INTRINSIC SPHINCTER DEFICIENCY. NO ADDITIONAL INFORMATION WAS PROVIDED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2010 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27148 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3413120

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention