BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2962319 · Received February 14, 2013

    Report

    Report Number
    2210968-2013-00951
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    May 2, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH MARSHALL-MARCHETTI PROCEDURE, MOSCHOWITZ CULDOPLASTY AND EXCISION OF STITCH FROM BLADDER; SUI, POP AND VESICAL CALCULUS. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL EXPLORATION AND EXCISION OF VAGINAL FOREIGN BODY SUTURE WITH FULGURATION AND CLOSURE OF SINUS TRACT ON (B)(6) 2006 DUE TO VAGINAL BLEEDING WITH A FOREIGN BODY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF ORIGINAL PELVICOL MESH ON (B)(6) 2007 DUE TO MESH EROSION. (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 A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. THE PATIENT ALSO UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2003 AND PELVICOL WAS IMPLANTED AND UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2007 AND URETEX TO 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
    65073 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA BPE730

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention