BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3170743 · Received June 14, 2013

    Report

    Report Number
    2210968-2013-07307
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2008 DUE TO CYSTOCELE, RECTOCELE, ENTEROCELE, AND BILATERAL PERIVAGINAL DEFECT. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND OTHER. IT WAS FURTHER REPORTED THAT ON (B)(6) 2008, THE PATIENT REMOVED MONARC MESH THAT WAS PREVIOUSLY IMPLANTED ON (B)(6) 2005 DUE TO MESH FAILURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS ALSO 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
    271146 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention