BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE

    MDR report key: 5208450 · Received November 6, 2015

    Report

    Report Number
    2125050-2015-00106
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    May 13, 2013
    Report Date
    August 21, 2015
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    OTO
    PMA / PMN Number
    K132061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. (B)(4). TOTAL NUMBER OF EVENTS REPORTED: (B)(4). (B)(4) - RESTORELLE. (B)(4) - NOVASILK NOVEMBER 06, 2015: REPORT WAS DELAYED DUE TO AN ESGG ISSUE. TICKET # (B)(4) WAS OPENED ON 10/30/2015 AND NOT RESOLVED UNTIL 11/06/2015.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH COLOPLAST OMNISURE AND RESTORELLE A TRAP MESH ON (B)(6) 2012. LATER THE PATIENT EXPERIENCED BUTTOCK PAIN 2 WEEKS AFTER OMNISURE SLING PLACEMENT, RECURRENT URINARY TRACT INFECTIONS AND INCONTINENCE. BETWEEN (B)(6) 2012 AND (B)(6) 2013 THE PATIENT WAS PRESCRIBED PAIN MEDICATIONS, NSAIDS AND ANTIMICROBIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737070 RESTORELLE SURGICAL MESH OTO COLOPLAST MANUFACTURING US, LLC 5013001400

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other