BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 3103073 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05366
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT ANTERIOR AND POSTERIOR VAULT REPAIR AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH, THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, RECURRENCE AND DYSPAREUNIA.(B)(4).

    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).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6) HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202863 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3453225

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention