BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3151332 · Received June 7, 2013

    Report

    Report Number
    2210968-2013-06700
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN; PAINFUL INTERCOURSE; URINARY LEAKAGE; CONTINUED URINARY INCONTINENCE; MESH EROSION; MESH PROTRUSION; ADDITIONAL SURGICAL PROCEDURE; RECURRENT BLADDER INFECTIONS; VAGINAL INFECTIONS; URINARY RETENTION AND PAINFUL URINATION; PSYCHOLOGICAL AND EMOTIONAL SUFFERING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 AND (B)(6) 2013 TO ALLEVIATE PAIN AND SUFFERING. (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

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED MIXED URINARY INCONTINENCE, FEELS DISCOMFORT WHEN SHE HAS FULL BLADDER AND URINARY URGENCY. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED CONCURRENTLY WITH VESICOURETHRAL SUSPENSION, DUE TO URINARY INCONTINENCE WITH POSITIVE (B)(6) TEST. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED MIXED URINARY INCONTINENCE, FEELS DISCOMFORT WHEN SHE HAS FULL BLADDER AND URINARY URGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252457 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2996704

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention