BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET

    MDR report key: 2022193 · Received March 11, 2011

    Report

    Report Number
    1820334-2011-00120
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 9, 2011
    Manufacturer
    COOK, INC.
    Product Code
    EZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXP DATE UNK AS LOT IS UNK. (B)(4): SUPERFICIAL ACID BURN. NO PRODUCT WAS RETURNED. AN IFU IS PROVIDED WITH THIS DEVICE THAT DESCRIBES PROPER INSERTION AND USAGE. PER THE QUALITY CONTROL SPEC IT IS CONFIRMED THE FLARE IS NOT FOLDED OVER IN ADAPTER, THE ADAPTER IS SECURE, AND THAT THE SLEEVE IS POSITIONED CORRECTLY. NO DEVICE WAS RETURNED TO ASSIST IN OUR INVESTIGATION. ADD'L INFO AS TO THE LOCATION OF THE LEAKAGE WAS REQUESTED, BUT NOT PROVIDED. WITHOUT ADD'L INFO WE ARE UNABLE TO DETERMINE WHERE THE LEAKAGE ORIGINATED FROM OR WHAT MAY HAVE LED TO THE LEAKAGE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS, HAVE NOTIFIED THE APPROPRIATE PERSONNEL. QUALITY ENGINEERING RISK ASSESSMENT DETERMINED THAT NO FURTHER MITIGATING ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    POST INSERTION, THE TUBE LEAKED GASTRIC CONTENT CAUSING SUPERFICIAL ACID BURN TO THE LEFT SIDE OF THE PT'S ABDOMEN. ADD'L INFO WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET EZK CATHETER, RETENTION TYPE EZK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK