BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENT PACK

    MDR report key: 19057204 · Received April 8, 2024

    Report

    Report Number
    1423395-2024-00330
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    October 4, 2023
    Report Date
    April 7, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OGR
    UDI-DI
    40195327151998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT "EXPLODED" DURING USE. NO SERIOUS INJURY OR ADVERSE IMPACT TO A PROCEDURE, PATIENT, OR 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. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED FOR EVALUATION. THE REPORTED PROBLEM/ISSUE WAS UNABLE TO BE CONFIRMED AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(4) 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 "EXPLODED" DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108512 ENT PACK OGR MEDLINE INDUSTRIES, LP DYNJ66039B 23EBQ764 40195327151998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other