BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3011441 · Received March 19, 2013

    Report

    Report Number
    2210968-2013-02494
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K0974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 MESH WAS IMPLANTED DUE TO HISTORY OF STRESS URINARY INCONTINENCE. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION AND URINARY PROBLEMS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION.

    Additional Manufacturer Narrative · 1

    PATIENT CODES: (B)(4) ¿ URINARY URGENCY, (B)(4) ¿ FREQUENCY, (B)(4) ¿ INFLAMMATION, (B)(4) ¿ BURNING ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED MONILIAL VAGINITIS, URINARY URGENCY, FREQUENCY AND BURNING ON URINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2002 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
    114258 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1047172

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention