BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3180069 · Received June 20, 2013

    Report

    Report Number
    2210968-2013-10635
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    March 18, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING MESH INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT TOTAL HYSTERECTOMY WITH MESH EXCISION AND REPAIR ON (B)(6) 2011. IT WAS FURTHER REPORTED THAT PATIENT HAD A FOREIGN OBJECT REMOVED FROM A LEFT BUTTOCK WOUND DUE TO MESH EXTRUSION THROUGH LEFT BUTTOCK. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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 PROCEDURE ON (B)(6) 2009 AND WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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
    280759 GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3008853

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention