BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-T AND A CDS

    MDR report key: 19056786 · Received April 7, 2024

    Report

    Report Number
    1423395-2024-00309
    Event Type
    Malfunction
    Date Received
    April 7, 2024
    Date of Event
    December 4, 2023
    Report Date
    April 6, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OGR
    UDI-DI
    40193489267342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT WAS FOUND TO BE CRACKED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. A SAMPLE WAS RETURNED FOR EVALUATION AND THE REPORTED PROBLEM/ISSUE WAS CONFIRMED. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT WAS FOUND TO BE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948012 DBD-T AND A CDS OGR MEDLINE INDUSTRIES, LP CDS983362C 23HBX082 40193489267342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other