BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF MD5096513

    MDR report key: 2993991 · Received February 27, 2013

    Report

    Report Number
    MW5029226
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    EHZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ORAL CARE SPONGE BROKE OFF IN PT'S MOUTH DURING ROUTINE ORAL CARE. THE HEAD OF THE ORAL CARE SPONGE NOTED TO SNAP OFF. DEVICE FAILURE CREATED AN UNSAFE CONDITION. DATES OF USE: (B)(6) 2013 - (B)(6) 2013. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84136 REF MD5096513 SUCTION SWAB KIT EHZ MEDLINE INDUSTRIES INC 1--80196802104 12353

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention BIOTENE DRY MOUTH ORAL RINSE