BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2963888 · Received February 15, 2013

    Report

    Report Number
    2210968-2013-01224
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A STAGE II- III RECTOCELE, WHICH OCCURRED 3.5 MONTHS AFTER LAH SURGERY. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A POSTERIOR REPAIR, SACROSPINOUS FIXATION OF THE VAGINA, AND REPAIR OF A STAGE II-III RECTOCELE DURING MESH IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, MESH EROSION, INFECTION, BLEEDING, VAGINAL SCARRING/SHRINKAGE AND EXPOSURE/EXTRUSION/PROTRUSION. THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67667 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL OTP ETHICON INC NA 3453221

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention