BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILTEX

    MDR report key: 274167 · Received April 18, 2000

    Report

    Report Number
    274167
    Event Type
    Injury
    Date Received
    April 18, 2000
    Date of Event
    January 7, 2000
    Report Date
    March 29, 2000
    Manufacturer
    MILTEX INSTRUMENT CO. INC.
    Product Code
    KCP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING IRRIGATION OF PT'S EAR, THE TOP OF THE SYRINGE DISLODGED WITH FORCE AND THE TIP PUNCTURED THE PT'S EAR DRUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILTEX SYRINGE, IRRIGATION KCP MILTEX INSTRUMENT CO. INC. 19-385 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention