BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP ON THE URODYNAMIC STUDY SYSTEM - UDS

    MDR report key: 21020192 · Received December 26, 2024

    Report

    Report Number
    MW5163951
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Report Date
    December 20, 2024
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    EXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: CALLER REPORTED THE PUMP ON THE UDS MACHINE WAS BROKEN. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5163950.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281339 PUMP ON THE URODYNAMIC STUDY SYSTEM - UDS CYSTOMETER, ELECTRICAL RECORDING EXQ LABORIE MEDICAL TECHNOLOGIES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown