BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3080321 · Received April 26, 2013

    Report

    Report Number
    2210968-2013-04543
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANTATION TO TREAT CYSTOCLE. IT WAS REPORTED THAT POST IMPLANTATION, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, VAGINAL SCARRING AND URINARY PROBLEMS AND UNDERWENT EXCISION OF EXPOSED MESH ON (B)(6) 2012. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME. (B)(4).

    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 FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, FREQUENCY OF URINATION, INFECTIONS AND NOCTURIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF LARGE AMOUNTS OF EXPOSED MESH AND A MODIFIED KELLY PLICATION OF CYSTOCELE, AND MULTIPLE CYSTOSCOPIES ON (B)(6) 2014 DUE TO EXPOSED MESH, AND ANTERIOR VAGINA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS 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
    182001 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3270113

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention