BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE 10,UNIVERSAL LTS

    MDR report key: 11095254 · Received December 30, 2020

    Report

    Report Number
    1518293-2020-00043
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 3, 2020
    Report Date
    December 3, 2020
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    PWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    505

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2020. REPORTER STATES THAT WHILE IN USE, THE COLLECTION BAG 10L (MFG# (B)(4)) LEAKED ALL OVER THE PHYSICIAN. THIS HAPPENED TWICE IN ONE DAY. HE STATES THE DESIGN HAS BEEN CHANGED. NEED TO FIND OUT IF THE DESIGN HAS BEEN CHANGED AND IF SO, CAN IT BE CHANGED BACK TO THE WAY IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563689 RELIANCE 10,UNIVERSAL LTS RELIANCE 10,UNIVERSAL LTS PWZ LIEBEL-FLARSHEIM 337210

    Patients

    Seq Age Sex Outcome Treatment
    1