BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE TOUCH SYS 100MM WITH LOOP OSTOMY ROD

    MDR report key: 3371524 · Received September 9, 2013

    Report

    Report Number
    1049092-2013-00008
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EZP
    PMA / PMN Number
    K811240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOOP ROD SAMPLE WAS BROKEN ALONG THE LONG AXIS. (B)(4) WAS RAISED. THE RETAIN SAMPLE WAS EXAMINED. COMPONENTS WERE PRESENT, ASSEMBLED PROPERLY AND CONSISTENT WITH PRODUCT SPECIFICATION REQUIREMENTS. THERE WAS NO EVIDENCE OF ANY MFG DEFECT. COMPONENTS USED WERE APPROVED FOR USE. THE LOOP ROD WAS EXAMINED AND THE SWIVEL END CHECKED. THE SWIVEL END WAS ROTATED 10 CYCLES AND EACH TIME CLICKED TO CORRECT LOCATION WITH NO EVIDENCE OF ANY STRESS TO THE SWIVEL OR LOOP ROD. THE BATCH RECORD REVIEW FOUND NO OBJECTIVE EVIDENCE OF DISCREPANCIES RELATED TO THE COMPLAINT ISSUE. CASE WAS IDENTIFIED DURING A RECENT FDA FACILITY INSPECTION. (B)(4).

    Description of Event or Problem · 1

    OPERATING ROOM MANAGER WITH UNITY HEALTH SYSTEM REPORTS THAT THIS MORNING A SURGEON OPENED A GENTLE TOUCH LOOP OSTOMY SYSTEM IN THE OPERATING ROOM, AND JUST PRIOR TO INSERTING THE ROD, THE SWIVEL TIP SNAPPED OFF. THE ROD HAD NO CONTACT WITH THE PATIENT. BOTH PIECES ARE TO BE RETURNED ALONG WITH THE GENTLE TOUCH PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449048 GENTLE TOUCH SYS 100MM WITH LOOP OSTOMY ROD ROD, COLOSTOMY EZP CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 020934 OH02364

    Patients

    Seq Age Sex Outcome Treatment
    1