BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2958564 · Received February 13, 2013

    Report

    Report Number
    2210968-2013-01055
    Event Type
    Injury
    Date Received
    February 13, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ONGOING PAIN AND RECURRENT URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION ON (B)(6) 2012 AND PARTIAL REMOVAL AND REVISION ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2006 DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, URINARY PROBLEMS AND DYSPAREUNIA. THE PATIENT HAD A HYSTERECTOMY SOMETIME IN (B)(6) 2007. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED EXPOSURE OF MESH AND UNDERWENT PARTIAL REMOVAL AND REVISION ON (B)(6) 2012. (B)(4).

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT I&D OF ABDOMINAL WALL HEMATOMA ON (B)(6) 2009 BY (B)(6) MD FOR AN ABDOMINAL WALL ABSCESS. PATIENT HAD A LAPAROSCOPY CONVERTED TO LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS AND LSO ON (B)(6) 2009 BY (B)(6) MD FOR LLQ PAIN AND COMPLEX CYSTIC MASS OF THE LEFT OVARY. PATIENT HAD TVH ON (B)(6) 2007 BY DR. (B)(6) FOR PELVIC PAIN AND MENORRHAGIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND AN OBTURATOR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT I&D OF ABDOMINAL WALL HEMATOMA ON (B)(6) 2009 BY (B)(6) MD FOR AN ABDOMINAL WALL ABSCESS. PATIENT HAD A LAPAROSCOPY CONVERTED TO LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS AND LSO ON (B)(6) 2009 BY (B)(6) MD FOR LLQ PAIN AND COMPLEX CYSTIC MASS OF THE LEFT OVARY. PATIENT HAD TVH ON (B)(6) 2007 BY DR. (B)(6) FOR PELVIC PAIN AND MENORRHAGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62753 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 2933520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention