BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3022501 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02971
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT PROCTOSCOPY WITH RECTOVAGINAL FISTULA REPAIR ON (B)(6) 2003. ON (B)(6) 2003, THE PATIENT HAD RE-EXPLORATION OF THE RECTOVAGINAL FISTULA REPAIR WITH REPAIR OF A FISTULA FROM THE RECTUM INTO THE REPAIR OF THE VAGINA DUE TO WOUND INFECTION AND REOPENING OF A RECTAL FISTULA.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2003.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINOPERINEAL RESECTION OF THE RECTUM WITH REPAIR OF PERISTOMAL HERNIA, RUPTURE OF OVARIAN CYSTS, APPENDECTOMY, AND PLACEMENT OF CENTRAL LINE ON (B)(6) 2006 DUE TO MALFUNCTIONING DYSFUNCTIONAL DISTAL RECTAL SEGMENT, SECONDARY TO INCONTINENCE, BIRTH TRAUMA AND IRREPARABLE INCONTINENCE WITH PROCTALGIA AND PERISTOMAL HERNIA. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS AND LSO ON (B)(6) 2006 DUE TO LEFT LOWER QUADRANT PAIN, PERSISTENT LEFT PELVIC MASS, CYSTIC IN STRUCTURE, COMPLEX. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT UNKNOWN PUBOVAGINAL SLING PLACEMENT ON (B)(6) 2007 DUE TO SUI. IT WAS REPORTED THAT PATIENT UNDERWENT OPEN NISSAN FUNDOPLICATION AND CHOLECYSTECTOMY ON (B)(6) 2008 DUE TO UNCONTROLLED REFLUX WITH BILIARY DYSKINESIA. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126320 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1038188

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention