BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK, NON-REBREATH W/ SAFETY VENT, PEDIATRIC

    MDR report key: 2092910 · Received April 11, 2011

    Report

    Report Number
    3004365956-2011-00147
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    March 22, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE VALVE BECAME UNATTACHED FROM THE MASK AND ENTERED THE PEDIATRIC PT'S MOUTH. ASSISTANCE FROM A MEDICAL TEAM WAS NEEDED TO REMOVE THE VALVE FROM THE PT'S MOUTH. FORCEPS HAD TO BE USED TO ASSIST IN THE REMOVAL PROCEDURE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASK, NON-REBREATH W/ SAFETY VENT, PEDIATRIC PEDIATRIC MASK KGB TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1