BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3182244 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10735
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 26, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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

    IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY AND SLING REVISION ON (B)(6) 2013 DUE TO VOIDING DYSFUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT A MONARCH TOT IMPLANT ON (B)(6) 2013. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF MID URETHRAL SLING MESH, REMOVAL OF POSTERIOR VAGINAL MESH AND BILATERAL TRIGGER POINT INJECTION DUE TO VAGINAL PAIN, DENSE ADHESIONS AND MESH ADHERENT TO RECTO VAGINAL SEPTUM AND DYSPAREUNIA ON (B)(6) 2015. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 2/15/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCOMPLETE BLADDER EMPTYING.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED UTI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED INTO THE PATIENT. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, URINARY INCONTINENCE, INFLAMMATION, SCAR TISSUE, DYSPAREUNIA, BLOOD LOSS, AND NEUROPATHIC INJURY. THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283777 UNK MESH, SURGICAL, SYNTHETIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention