BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 3030884 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03293
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 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): ON (B)(6) 2010, THE PATIENT HAD AN AJUST BARD SLING IMPLANTED DUE TO CYCTOCELE, RECTOCELE AND URINARY STRESS INCONTINENCE. IT WAS ALSO REPORTED THAT A REMOVAL/REVISION SURGERY OF THE SLING WAS DONE ON (B)(6) 2011 DUE TO URINARY RETENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR AND POSTERIOR VAGINAL REPAIR WITH CLOSURE OF ENTEROCELE, UTERINE SUSPENSION AND SUBURETHRAL MESH PLACEMENT AND CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR COLPORRHAPHY WITH PERINEORRHAPHY AND REMOVAL OF POSTERIOR VAGINAL WALL MESH ON (B)(6) 2011 AND EMPLOYED AN I-STOP (RETROPUBIC BLADDER NECK SLING).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH AND ADJUST-ADJUSTABLE SINGLE-INCISION SLING WERE IMPLANTED. 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
    133590 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3453226

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention AJUST-ADJUSTABLE SINGLE-INCISION SLING