BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2770664 · Received October 3, 2012

    Report

    Report Number
    2210968-2012-05836
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2014 DUE TO CHRONIC UTI. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT VAGINAL VAULT PROLAPSE, AND STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT CONCURRENT PROCEDURES TO REPAIR A RECTOCELE, CYSTOCELE, URETHROCELE AND ENTEROCELE DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT ALSO HAD A FLOSEAL HEMOSTATIC MATRIX [BAXTER HEALTHCARE CORPORATION] IMPLANTED ON (B)(6) 2009. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, AND URINARY PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). 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).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 01/12/2017. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS, URINARY FREQUENCY, URGENCY AND INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL ITCHING AND VULVAR ABSCESS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. PATIENT (B)(4) - DYSPAREUNIA, (B)(4) BLADDER PROBLEMS. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, BLADDER PROBLEMS, DYSPAREUNIA, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS, URINARY FREQUENCY, URGENCY AND INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3256649

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention FLOSEAL HEMOSTATIC MATRIX