BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3040333 · Received April 8, 2013

    Report

    Report Number
    2210968-2013-03567
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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). 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 FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, DYSPAREUNIA AND ORGAN PERFORATION. ON (B)(6) 2011 THE PATIENT UNDERWENT CYSTOLITHOLAPAXY AND PARTIAL REMOVAL DUE TO MESH EXTRUSION INTO BLADDER. IT WAS REPORTED THAT ON (B)(6) 2012 CYSTOLITHOLAPAXY AND REMOVAL OF MESH WERE PERFORMED DUE TO BLADDER STONE AND FOREIGN BODY WITH MESH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC PAIN, STRESS URINARY INCONTINENCE, LIMITED PELVIC FLOOR RELAXATION, AND ENDOMETRIOSIS. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF OPERATIVE LAPAROSCOPY, EXTENSIVE LYSIS OF ADHESIONS, LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, AND LEFT SALPINGO-OOPHORECTOMY DURING MESH IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2004 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143189 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1163827

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention