BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-NASAL PACK

    MDR report key: 19056796 · Received April 7, 2024

    Report

    Report Number
    1423395-2024-00318
    Event Type
    Malfunction
    Date Received
    April 7, 2024
    Date of Event
    August 30, 2023
    Report Date
    April 7, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OGR
    UDI-DI
    40195327062157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT BROKE. NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR A USER WAS ORIGINALLY REPORTED. 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 PHOTO WAS PROVIDED FOR REVIEW AND THE REPORTED PROBLEM/ISSUE WAS CONFIRMED. NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION. 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 BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948022 DBD-NASAL PACK OGR MEDLINE INDUSTRIES, LP DYNJ44137C 23ABJ852 40195327062157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other