BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH

    MDR report key: 3163269 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10153
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO RECTOCELE, CYSTOCELE, VAGINAL VAULT PROLAPSED AND URINARY INCONTINENCE. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, BLEEDING, URINARY PROBLEMS AND DYSPAREUNIA.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH SUPRAPUBIC CYSTOSTOMY, CYSTOCELE/ RECTOCELE REPAIR.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2017 BY DR. (B)(6) AT (B)(6) WOMEN AND CHILDREN DUE TO INCONTINENCE AND URINARY FREQUENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS 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
    264259 GYNECARE GYNEMESH MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention