BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3232481 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13557
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    September 27, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WERE IMPLANTED DUE TO SUI, POP. IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING AND URINARY, BOWEL AND NEUROMUSCULAR PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY FREQUENCY, NOCTURIA, AND VOIDING DYSFUNCTION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2015 BY (B)(6) DUE TO GRAFT COMPLICATIONS AT (B)96) CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. THERE IS ALSO MENTION OF AVAULTA BIO-SYNTHETIC SUPPORT SYSTEMS. NO CLARIFYING INFORMATION IS PROVIDED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND 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
    333262 GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3413270

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention BARD| BARD