BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3132884 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05962
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 9, 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

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2005 DUE TO STRESS URINARY INCONTINENCE. THE PATIENT THEN FELT PAIN, EROSION, INFECTION, FISTULAE, RECURRENCE AND URINARY AND BOWEL PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT RESECTION OF SIGMOID COLON FISTULA FORMED FROM BLADDER MESH ON (B)(6) 2012. IT WAS FURTHER REPORTED PATIENT HAD EXCISION OF CHRONIC LEFT LOWER QUADRANT DRAINING ABDOMINAL WOUND ON (B)(6) 2013. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC RESECTION OF SIGMOID COLON FISTULA, DRAIN, ABDOMINAL WALL ABSCESS, AND REPAIR OF LEFT SPIGELIAN HERNIA ON (B)(6) 2012 DUE TO LEFT SPIGELIAN HERNIA WITH INTERMITTENT INCARCERATION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, RELEASE OF SMALL BOWEL OBSTRUCTION, AND SMALL BOWEL RESECTION ON (B)(6) 2015 DUE TO BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH 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
    236361 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1250974

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention