BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE

    MDR report key: 24764474 · Received April 1, 2026

    Report

    Report Number
    MW5186292
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Report Date
    March 24, 2026
    Manufacturer
    UNKNOWN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION 803.22, WE WISH TO INFORM YOU OF AN ADVERSE EVENT ASSOCIATED WITH ANOTHER MANUFACTURER'S DEVICE WHICH HAS BEEN RECEIVED AT ALLERGAN INC. ((B)(6) REF (B)(4)). ALLEGED EVENT: SALES REPRESENTATIVE REPORTED ¿I KNOW YOU ALREADY KNOW THIS BUT THE NEW NEEDLES THE COVER SLIPS OFF HARD TO KEEP STERILE" OF A NON-(B)(6) DEVICE. THIS RECORD IS FOR UNKNOWN SIDE. THE DEVICE STATUS IS UNKNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030 NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown