BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2760509 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05637
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (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 VAGINAL PAIN, EROSION AND DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT CONCURRENT LAPAROSCOPIC VAGINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF MESH ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO VAGINAL MESH EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF MESH ON (B)(6) 2014 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO MESH COMPLICATIONS EROSION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED TO TREAT PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010 DUE TO EROSION, VAGINAL PAIN AND DYSPAREUNIA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 WITH EXCISION OF MESH (NO DETAILS) DUE TO PATIENT EXPERIENCING RECURRENCE OF STRESS URINARY INCONTINENCE, INABILITY TO VOID, AND DYSPAREUNIA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2005, (B)(6) 2005 AND (B)(6) 2006 AND MESH, PERIGEE AND ADVANTAGE WERE USED. IT WAS NOT STATED WHICH PRODUCT WAS USED DURING WHICH SURGERY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1377567

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention ADVANTAGE| PERIGEE| ADVANTAGE