BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2963347 · Received February 15, 2013

    Report

    Report Number
    2210968-2013-01183
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

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

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2015 BY DR. (B)(6) AT (B)(6) DUE TO RECURRENT UTI, MESH COMPLICATION, DYSPAREUNIA, CYSTOCELE AND URINARY OBSTRUCTION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 BY DR. (B)(6), M.D. AT (B)(6), DUE TO URINARY RETENTION SECONDARY TO URETHRAL OUTLET OBSTRUCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, MESH EROSION, INFECTION, BLEEDING, VAGINAL SCARRING/SHRINKAGE AND EXPOSURE/EXTRUSION/PROTRUSION, THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2015 BY DR. (B)(6) AT (B)(6) DUE TO RECURRENT UTI, MESH COMPLICATION, DYSPAREUNIA, CYSTOCELE AND URINARY OBSTRUCTION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 BY DR. (B)(6), M.D. AT (B)(6), DUE TO URINARY RETENTION SECONDARY TO URETHRAL OUTLET OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67499 TENSION FREE VAGINAL TAPE MESH, SURGICAL OTN ETHICON INC NA 3443188

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention