BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3182625 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-07460
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, RECURRENCE, AND DYSPAREUNIA. (B)(4). 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED CONCURRENTLY WITH URETHRAL DILATATION AND CYSTOSCOPY DUE TO SUI, CHRONIC CYSTITIS, AND LEFT RENAL STONE. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR MRSA DUE TO MESH INFECTION ON (B)(6) 2008; CYSTOSCOPY WITH PLACEMENT OF URETHRAL CATHETER AND RETROGRADE URETEROGRAM ON (B)(6) 2008 DUE TO LEFT RENAL CALCULUS, PERSISTENT UTI, AND OBSTRUCTIVE MESH WITH URINARY OBSTRUCTION; A, LEFT RETROGRADE PYELOGRAM, INSERTION OF JJ TUBE AND URETHRAL DILATATION ON (B)(6) 2015 DUE TO LEFT RENAL CALCULUS AND DIFFICULTY IN URINATION; AND CYSTOSCOPY, REMOVAL OF LEFT URETERAL STENT, LEFT URETERAL CATHETERIZATION WITH RETROGRADE, AND LEFT ESWL ON (B)(6) 2015 DUE TO LEFT RENAL CALCULUS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS ALSO 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
    284016 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2950580

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention