BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3221204 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12845
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    March 30, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED DUE TO URODYNAMIC STRESS INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE AND VAGINAL SCARRING.NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED ON (B)(6) 2009 DUE TO PERSISTENT LEFT OVARIAN CYST WITH ABDOMINAL INCISIONAL HERNIA; WORSENING STRESS URINARY INCONTINENCE; SYMPTOMATIC BOWEL PROLAPSE AND HYPERTROPHIC SCAR WITH CONCURRENT EXPLORATORY LAPAROTOMY WITH BILATERAL EXCISIONS OF HYDROSALPINX; EXCISIVE LYSIS OF ADHESIONS; ABDOMINAL VAGINAL SACROPEXY; BURCH RETROPUBIC URETHROPEXY, ABDOMINAL INCISIONAL HERNIA REPAIR AND SCAR REVISION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, DYSPAREUNIA AND OTHER INJURIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT 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
    319747 UNKNOWN MESH, SURGICAL, SYNTHETIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention