BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 4782157 · Received May 19, 2015

    Report

    Report Number
    2210968-2015-06060
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    April 20, 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: 04/7/2016. IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011 BY DR. (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPASROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2008.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 5/5/2016, (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, DYSPAREUNIA, URGE INCONTINENCE AND VAGINAL SCARRING.

    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

    IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF SLING AND CYSTOSCOPY ON (B)(6) 2012 BY DR. (B)(6) MEDICAL CENTER DUE TO MESH EXTRUSION INTO THE VAGINA SECONDARY TO MID-URETHRAL SLING (PER OPERATIVE REPORT).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND 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
    326994 GYNECARE MESH UNKNOWN OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention