BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2963934 · Received February 15, 2013

    Report

    Report Number
    2210968-2013-01208
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON INC
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY ON (B)(6) 2010 CONCURRENTLY WITH BILATERAL RETROGRADE PYELOGRAM, BILATERAL URETERAL CATHETER PLACEMENT AND PELVIC EXPLORATION, URETERAL STENTS, EXPLORATORY LAPAROTOMY, ADHESIOLYSIS AND REPAIR OF SMALL BOWEL ENTEROTOMY DUE TO POSSIBLE URINARY SYSTEM INJURY/ SMALL BOWEL INJURY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT POST INSERTION PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, DYSPAREUNIA, AND URINARY/BOWEL PROBLEMS. (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.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) 2010 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    67853 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON INC NA 3308709

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention