BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2792417 · Received October 16, 2012

    Report

    Report Number
    2210968-2012-06583
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED URINARY TRACT INFECTION, LEAKAGE, URGENCY, AND URINARY RETENTION.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06584. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRUSION, INFECTION, RECURRENCE, URINARY AND BOWEL PROBLEMS AND ORGAN PERFORATION POST IMPLANTATION. ON (B)(6) 2002, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT INCONTINENCE. ON (B)(6) 2003, THE PATIENT UNDERWENT POSTERIOR COLPORRHAPHY AND PERINEORRHAPHY TO TREAT SYMPTOMATIC RECTOCELE. ON (B)(6) 2007, THE PATIENT UNDERWENT ANTERIOR COLPORRHAPHY, CYSTOTOMY REPAIR, POSTERIOR RECTAL ENTEROCELE REPAIR. ON (B)(6) 2009, THE PATIENT ALSO UNDERWENT LYSIS OF ADHESIONS, LEFT SO, TO TREAT PELVIC PAIN, CYSTOCELE, ENTEROCELE. (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00744. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 GYNECOLOGICAL PROCEDURES ON (B)(6) 2002, (B)(6) 2007 AND (B)(6) 2009 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 936032

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention