BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2983436 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01944
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005. THE PATIENT UNDERWENT CYSTOLITHOLAPAXY AND ENDOSCOPIC REMOVAL OF FOREIGN BODY ON (B)(6) 2010. ON (B)(6) 2010 THE PATIENT UNDERWENT TRANSURETHRAL REMOVAL OF INTRAVESICAL FOREIGN BODY. IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT EXCISION OF FOREIGN BODY FROM BLADDER, ERODED MESH, HOLMIUM LASER LITHOTRIPSY AND BLADDER STONE SURGERY. THE PATIENT UNDERWENT FISTULA REPAIR VESICOVAGINAL, OPEN REMOVAL OF FOREIGN BODY IN BLADDER, EXCISION OF EXPOSED MESH PROSTHESIS, AND CYSTOSCOPY ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT REPORTED LEAKING ON (B)(6) 2012.

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE AND CYSTOCELE. THE PATIENT UNDERWENT MESH REMOVAL PROCEDURES ON (B)(6) 2010 DUE TO FOREIGN BODY IN THE URINARY BLADDER. IT WAS REPORTED THAT SHE UNDERWENT REMOVAL OF BLADDER STONE PROCEDURE ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2005 AND MESH AND BOSTON SCIENTIFIC OBTRYX WERE IMPLANTED. IT WAS REPORTED THAT SHE 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
    86302 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC NA UBE008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC OBTRYX