BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3151702 · Received June 7, 2013

    Report

    Report Number
    2210968-2013-06723
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2002 IN ORDER TO TREAT STAGE TWO CYSTOCELE, AND STRESS URINARY INCONTINENCE WITH POSTERIOR STRUCTURE CONCURRENTLY WITH RELEASE OF PERINEAL STRICTURE, ANTERIOR REPAIR WITH BILATERAL VAGINAL VAULT SUSPENSION, AND A CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT RESECTION OF VAGINAL ADHESIONS, LAPAROSCOPIC SACROCOLPOPEXY, RIGHT URETEROLYSIS, AND LYSIS OF ADHESIONS ON (B)(6) 2008. 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.THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-06717. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, URINARY TRACT INFECTION, URINARY URGENCY, NOCTURIA, AND SENSATION OF INCOMPLETE EMPTYING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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 HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, URINARY TRACT INFECTION, URINARY URGENCY, NOCTURIA, AND SENSATION OF INCOMPLETE EMPTYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252409 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 955563

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention