BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD WARMING SET W/48" EXT

    MDR report key: 2232551 · Received July 19, 2011

    Report

    Report Number
    1313850-2011-00173
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AT FILING DATE, PRODUCT HAD NOT BEEN RETURNED FOR MANUFACTURER'S EVALUATION. FOLLOW-UP WILL BE ISSUED IF NECESSARY BASED UPON INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD A NUMBER OF CASSETTES RUPTURE OR BURST DURING A PROCEDURE. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STD WARMING SET W/48" EXT FLUID CASSETTE LGZ STRYKER CORP DBA GAYMAR D25310NL M1511-2014

    Patients

    Seq Age Sex Outcome Treatment
    1