BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972700 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01453
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY AND CYTOTOMY.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RELEASE, EXCISION, AND EXTRACTION OF TVT MESH WITH A HIGH KELLY URETHRAL PLICATION CYSTOURETHROSCOPY ON (B)(6) 2014 BY DR. (B)(6) AT (B)(6) HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED INFECTION, SCARRING AND URINARY PROBLEMS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, URINARY URGENCY, URINARY RETENTION, HEMATURIA AND SEVERE VAGINAL DISCHARGE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THE GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE WITH INTRINSIC SPHINCTER DEFICIENCY, AND RECURRENT OVERACTIVE BLADDER. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 AND A SLING WAS IMPLANTED. 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
    76661 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3447680

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention