BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2991562 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02057
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH, THE PATIENT EXPERIENCED PAIN, INFECTION AND URINARY PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT URETHRAL HYPERMOBILITY, URGE URINARY INCONTINENCE, AND INTRINSIC SPHINCTER DEFICIENCY. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A CYSTOSCOPY AND EXCISION OF RIGHT LABIAL CYST PERFORMED DURING MESH IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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

    RESUBMISSION WITH THE CORRECT FILE NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 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
    96157 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3374570

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention