BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2772416 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-06040
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/22/2015. ADDITIONAL NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF VAGINAL GRAFT BY THE VAGINAL ROUTE ON (B)(6) 2012 DUE TO EROSION OF VAGINAL GRAFT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, CYSTOCELE, RECTOCELE, AND ANAL SPHINCTER AND MESH WAS IMPLANTED.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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06041. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS CONCURRENTLY WITH ANTERIOR/POSTERIOR REPAIR AND SPHINCTEROPLASTY. IT WAS REPORTED THAT THE PATIENT UNDERWENT INSERTION OF PERIPHERAL NEUROSTIMULATOR PULSE GENERATOR AND ELECTRONIC ANALYSIS OF IMPLANTED NEUROSTIMULATOR PULSE GENERATOR SYSTEM WITH INTRAOPERATIVE SUBSEQUENT PROGRAMMING ON (B)(6) 2014 DUE TO URINARY URGENCY AND SUI. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 06/06/2016.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL BLEEDING AND DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY RETENTION.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 02/16/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL BLEEDING AND DYSPAREUNIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 2978403

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention