BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2882795 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08175
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 2, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED PAIN, INFECTION AND URINARY/BOWEL PROBLEMS. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TVH, BILATERAL SALPINGECTOMY, A&P REPAIR, PERINEORRHAPHY, SKIN TAG REMOVAL AND CYSTOSCOPY; DUE TO MIXED INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2014 BY IMPLANTING SURGEON DUE TO URINARY RETENTION AND PERINEAL LAXITY.

    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

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, URINARY RETENTION, URINARY INCONTINENCE AND ADHESIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY AND URINARY FREQUENCY.

    Additional Manufacturer Narrative · 1

    PATIENT CODES: (B)(4) ¿ BLEEDING, (B)(4)- ITCHING ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BLEEDING AND ITCHING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS USED. THE PATIENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2014 BY IMPLANTING SURGEON DUE TO URINARY RETENTION AND PERINEAL LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3594105

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention