BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2991502 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02148
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 11, 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

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT 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.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A SYMPTOMATIC RECTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, RECURRENCE AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH EROSION THROUGH THE VAGINA AND UNDERWENT MESH REVISION ON (B)(6) 2013 OF THE OBTRYX SLING SYSTEM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO VAGINAL PROLAPSE AND RECTOCELE. THE PATIENT UNDERWENT MESH REVISION DUE TO MESH EROSION AND PELVIC PAIN ON (B)(6) 2008 AND (B)(6) 2013 RESPECTIVELY. ON (B)(6) 2011, THE PATIENT UNDERWENT A PROCEDURE OF INJECTIONS INTO THE VAGINA FOR PAIN RELIEF.

    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 SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. THERE WAS AN ADDITIONAL SURGERY ON (B)(6) 2007, AND A BOSTON SCIENTIFIC PRODUCT WAS IMPLANTED; HOWEVER, THIS SURGERY WAS NOT REPORTED IN THE COMPLAINT. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95176 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 06143453221

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention BOSTON SCIENTIFIC PRODUCT