BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE Y SHAPED

    MDR report key: 6354335 · Received February 23, 2017

    Report

    Report Number
    2125050-2017-00027
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    May 19, 2014
    Report Date
    February 23, 2017
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K112322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. OTO EXEMPTION NUMBER E2014015. TOTAL NUMBER OF EVENTS SUMMARIZED - 27. RESTORELLE - 23. NOVASILK - 4 - ATTACHMENT: [OTO DEC JAN 2016-17 .ZIP].

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED CHRONIC PELVIC PAIN, DYSPAREUNIA AND DEFECATORY DYSFUNCTION WITH CHRONIC CONSTIPATION; VAGINAL CUFF TENDERNESS. PREOPERATIVE DIAGNOSIS : PELVIC PAIN; DYSPAREUNIA; TRANSVAGINAL MESH EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136579 RESTORELLE Y SHAPED SURGICAL MESH OTO COLOPLAST A/S 5014301400

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other