BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G BONE CEMENT WITH GENTAMICIN

    MDR report key: 7809352 · Received August 22, 2018

    Report

    Report Number
    MW5079335
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 17, 2018
    Report Date
    August 20, 2018
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    MBB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CEMENT IS PALACOS R+G BONE CEMENT WITH GENTAMICIN #00-1113-140-01 WITH LOT #8934752 - TEMPT IN OPERATING ROOM 68.4; HUMIDITY = 17.8 AS PER SIEMENS INDICATOR INSIDE THE ROOM. ORTHO SURGEON REQUESTED THAT LOT BE INVESTIGATED AND REMOVED FROM SUPPLY UNTIL CLEARED. HE STATED THAT THIS HAS OCCURRED BEFORE. DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: STICKY AND DIFFICULT TO MANAGE CEMENT AFTER MIXING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645617 PALACOS R+G BONE CEMENT WITH GENTAMICIN BONE CEMENT, ANTIBIOTIC MBB HERAEUS MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1