BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3020580 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02909
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT PATIENT UNDERWENT REPLACEMENT OF FALLEN MESH WITH BOSTON SCIENTIFIC UPHOLD SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL WITH ENTEROCELE REPAIR ON AN UNDISCLOSED DATE.

    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. 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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2007 IN ORDER TO TREAT CYSTOCELE, RECTOCELE, AND INCONTINENCE CONCURRENTLY WITH AN ANTERIOR AND POSTERIOR COLPORRHAPHY. IT WAS REPORTED THAT THE PATIENT UNDERWENT BACK SURGERY IN 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION AND ENTEROCELE REPAIR ON (B)(6) 2011 DUE TO ERODED VAGINAL MESH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 7/31/2017 ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXTRUDED MESH ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXTRUDED VAGINAL MESH AND PLACEMENT OF A RETROPUBIC BIOARC AMS RETROPUBIC SLING ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL WALL MESH ON (B)(6) 2015 AND ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. ON (B)(6) 2008 BOSTON SCIENTIFIC ADVANTAGE MESH WAS IMPLANTED AND ON (B)(6) 2010 BOSTON SCIENTIFIC UPHOLD WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    124555 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3067816

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention