BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 3131951 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05943
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 10, 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

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED DUE TO SUI AND POP. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY & BOWEL PROBLEMS, AND RECURRENCE.(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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05942. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, MESH EROSION, INFECTION, BLEEDING, VAGINAL SCARRING/SHRINKAGE AND EXPOSURE/EXTRUSION/PROTRUSION, AND SHE 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
    234413 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3270157

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention