BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3163175 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-07025
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING, AND OTHER OUTCOMES FOLLOWING THE PROCEDURE. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR AND POSTERIOR REPAIR, BILATERAL SACRAL SPINOUS FIXATION, PLACEMENT OF TWO TUNNELED SUBFASCIAL CATHETERS FOR ON-Q PUMP, INGUINAL HERNIA REPAIR AND ABDOMINOPLASTY DUE TO SUI, CYSTOCELE, AND RECTOCELE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 AND A MESH AND BOSTON SCIENTIFIC ADVANTAGE WERE 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
    263461 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3089795

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC ADVANTAGE