BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK SYR EAR COMP 4OZ O-G

    MDR report key: 2423058 · Received January 18, 2012

    Report

    Report Number
    2523190-2012-00011
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 23, 2011
    Report Date
    January 18, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KCP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6)_2012, THE NURSE MANAGER REPORTED THE PT HAD HER EARS IRRIGATED ON (B)(6) 2011 FOR THE REMOVAL OF EAR WAX. THE PHYSICIAN WAS ABLE TO IRRIGATE THE PT'S LEFT EAR WITH 350 CC OF WARM WATER WITHOUT INCIDENT. WHEN SHE IRRIGATED THE RIGHT EAR, SHE USED 2000 CC OF WARM WATER, THE SYRINGE SEEMED STIFF AND THE PLUNGER BROKE AND THE TIP OF THE SYRINGE PUSHED INTO THE PT'S RIGHT EAR CAUSING IMMEDIATE PAIN. THE PT HAD A VASOVAGAL REACTION AND FELT NAUSEATED. HER BLOOD PRESSURE WAS 114.82 AND HER PULSE WAS 88. THE PT'S RIGHT EAR WAS BLEEDING AND SHE WAS IMMEDIATELY SENT TO TO SEEN BY AN ENT PHYSICIAN. THE NURSE HAD NO ADDITIONAL INFORMATION SURROUNDING THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCK SYR EAR COMP 4OZ O-G M11 - ENT KCP INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR