BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVID CUSTOM PROCEDURE TRAYS

    MDR report key: 6577943 · Received May 16, 2017

    Report

    Report Number
    MW5069865
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    December 12, 2017
    Report Date
    May 16, 2017
    Manufacturer
    OWENS & MINOR, INC.
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED CHLORAPREP PACKAGE HAD BURST OPEN; 26 ML W / APP, REF (B)(4). MFR DATE: 09/15/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352646 AVID CUSTOM PROCEDURE TRAYS PACEMAKER PACK: TRAY SURGICAL LRP OWENS & MINOR, INC. 1193744

    Patients

    Seq Age Sex Outcome Treatment
    1