BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEIN

    MDR report key: 519154 · Received March 29, 2004

    Report

    Report Number
    519154
    Event Type
    Injury
    Date Received
    March 29, 2004
    Date of Event
    June 3, 2003
    Report Date
    March 23, 2004
    Manufacturer
    RHEIN MEDICAL
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOREIGN BODY IN OD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEIN IA HANDPIECE HEX HANDLE HQE RHEIN MEDICAL 99IH90100 R *
    2 RHEIN ASSORTED TIPS-45 IA TIP KYG RHEIN MEDICAL 99IH 90303 *
    3 RHEIN BINKHORST 180 IA TIP KYG RHEIN MEDICAL 99IH 90306 *
    4 RHEIN STRAIGHT IA TIP .3MM KYG RHEIN MEDICAL 99IH 90301 *
    5 RHEIN STRAIGHT SILICONE SLEEVE .3MM KGY RHEIN MEDICAL 99IH 90307 *
    6 RHEIN CURVED SILICONE SLEEVE .3MM KYG RHEIN MEDICAL 99IH 90311 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention