BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 2970148 · Received February 20, 2013

    Report

    Report Number
    2210968-2013-01478
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    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

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT UTERINE DESCENSUS, FIBROID (14 WEEK SIZE UTERUS) WITH DYSFUNCTIONAL BLEEDING AND SYMPTOMATIC RECTOCELE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY/ BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, INTERCEED, PLACEMENT OF ON-Q PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURES ON (B)(6) 2006 AND A MESH 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
    73645 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON SARL A JOHNSON & JOHNSON COMPANY NA 2893626

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTERCEED| ON-Q