BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 4781923 · Received May 19, 2015

    Report

    Report Number
    2210968-2015-06043
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    April 27, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 4/8/2016.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT INTERSTIM BATTERY PACK REMOVAL AND INTERSTIM IMPLANT ON (B)(6) 2009 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO URGE INCONTINENCE AND EXPIRED INTERSTIM DEVICE. IT WAS REPORTED THAT PATIENT UNDERWENT INTRAVESICAL BOTOX INJECTION (200 UNITS) ON (B)(6) 2011 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO INCONTINENCE, URGENCY, AND FREQUENCY. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF OLD INTERSTIM DEVICE AND IMPLANT AND PLACEMENT OF NEW INTERSTIM DEVICE AND IMPLANT ON (B)(6) 2011 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO URGE INCONTINENCE AND INTERSTIM BATTERY EXPIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 AND AN UNK GYNECARE PELVIC MESH PRODUCT AND A NON-GYNECARE PELVIC MESH PRODUCT 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
    326408 GYNECARE MESH UNKNOWN OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention