BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972960 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01571
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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): IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL/REVISION ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/19/2016. (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010, AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE TRIGGER POINT INJECTIONS WITH BOTOX ON (B)(6) 2012, DUE TO VAGINAL MESH INSERTION COMPLICATIONS WITH CHRONIC PELVIC PAIN AND PENETRATION OF THE MESH THROUGHOUT THE PELVIC ORGANS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BLADDER SPASMS, URINARY PROBLEMS AND INFECTIONS.IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENSIVE TRANSVAGINAL URETHROLYSIS, REPAIR OF CENTRAL DEFECT USING VICRYL SUTURES, EXCISION OF POSTERIOR PROXIMAL VAGINAL WALL SCAR WITH REPAIR OF PROXIMAL VAGINAL ON (B)(6) 2013 BY DR. (B)(6).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL HYSTERECTOMY, UTEROSACRAL VAGINAL VAULT SUSPENSION, ANTERIOR POSTERIOS ENTEROCYLE REPAIR SURGERY ON (B)(6) 2010 AND A 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75817 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3413099

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention