BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TONSIL SNARE SIZE 7 STERILE

    MDR report key: 22239859 · Received June 17, 2025

    Report

    Report Number
    3002750084-2025-00027
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Report Date
    June 17, 2025
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    KBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVIDE WAS NOT RETURNED, HOWEVER DEVICES FROM THE SAME LOT WERE RETURNED FOR EVALUATION. NO PICTURES WERE PROVIDED. THE MALFUNCTION COULD NOT BE REPRODUCED, AND WITHOUT EITHER THE PROBLEM DEVICE OR PICTURES THE COMPLAINT COULD NOT BE CONFIRMED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "THIS EMAIL IS IN REGARDS TO TONSIL SNARE #2407, LOT#412643. MY TEAM RECEIVED A COMPLAINT THAT THESE TONSIL SNARES WERE BREAKING DURING THE SURGICAL PROCEDURE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28534 TONSIL SNARE SIZE 7 STERILE TONSIL SNARE KBZ ASPEN SURGICAL PRODUCTS, INC. 2407 412643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown