BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIPS SONICARE

    MDR report key: 2608642 · Received May 31, 2012

    Report

    Report Number
    3026630-2012-00003
    Event Type
    Other
    Date Received
    May 31, 2012
    Date of Event
    January 10, 2012
    Report Date
    May 31, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO ORGANISMS IDENTIFIED ARE RELATIVELY COMMON, TYPICAL TO FIND IN THE EVERY DAY ENVIRONMENT; BUT IN IMMUNE-COMPROMISED HOSTS, CAN CAUSE OPPORTUNISTIC INFECTIONS, PARTICULARLY OF THE RESPIRATORY TRACT. HOW AND WHEN THE ORGANISMS GOT INTO THE TUBING HAS NOT BEEN DETERMINED AND MAY NOT BE ABLE TO BE DETERMINED. ALTHOUGH THE OPPORTUNITY FOR LIQUID ASPIRATION APPEARS TO BE VERY SMALL WE CANNOT RULE OUT THAT THE UNIT WAS OR WAS NOT A CONTRIBUTING FACTOR TO THE USER'S CONDITION. ON 01/10/2012 COMPLAINT FILED IN OUR INTERNATIONAL COMPLAINT HANDLING DATABASE. ON 01/20/2012 INITIAL MDR ASSESSMENT PERFORMED BASED ON INFO AVAILABLE, DETERMINED THAT IT WAS NOT MDR REPORTABLE. REQUESTED MORE INFO FROM CONSUMER CARE MGR, (B)(4). ON (B)(6) 2012, CONSUMER DID NOT GO TO THE HOSPITAL BEFORE CONSULTING THEIR GENERAL PHYSICIAN. ON 02/02/2012 HELD HEALTH RISK EVAL MEETING, WAITING FOR MORE INFO AND THE DEVICE TO BE RETURNED. ON (B)(6) 2012, CONSUMER STATES THAT THEY HAVE NEVER HAD A RESPIRATORY PROBLEM, OR EVER SMOKED. CONSUMER STATES THEY NOTICED AFTER 2 WEEKS OF USE THEY WERE SHORT OF BREATH AT NIGHT. ON 02/13/2012 RECEIVED UNIT AND SENT TO QA LAB FOR EVAL. ON 03/27/2012 UPON FURTHER EVAL OF THE DEVICE, THE PRODUCT QUALITY TEAM FOUND SOME FORM OF RESIDUE ON THE INSIDE WALL OF THE TUBING JUST BEFORE THE DROP GENERATOR. ON 04/02/2012 INTERNAL TUBING WITH RESIDUE WAS SENT TO (B)(4) FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CONSUMER CLAIMS TO HAVE AN UPPER AIRWAY INFECTION DUE TO THE USE OF AIRFLOSS. ON (B)(6) 2012, CONSUMER STATES THAT THEY HAVE NEVER HAD A RESPIRATORY PROBLEM. CONSUMER STATES THAT THEIR SYMPTOMS WERE SEVERE BREATHLESSNESS - VISITED GENERAL PHYSICIAN ON 3-4 OCCASIONS WHO TOOK FEV (LUNG FUNCTION) TESTS WITH A SPIROMETER AND ALSO SUPPLIED THEM WITH A TAKE HOME SPIROMETER TO MONITOR PROGRESS. CONSUMER SAYS THAT THEY WERE GIVEN TWO DIFFERENT METER DOSE INHALERS. CONSUMER CLAIMS THAT THEY DID NOTICE THAT AFTER USING AIRFLOSS WAS WHEN THEY FELT 'MORE BREATHLESS.' CONSUMER STATES THAT WHEN THEY COMPLETELY STOPPED USING THE AIRFLOSS, WITHIN APPROX 2-3 WEEKS CONSUMER FELT CONSIDERABLY LESS BREATHLESS AND THEIR SPIROMETER RESULTS IMPROVED CONSIDERABLY. CONSUMER STATES THAT AFTER A FURTHER 1-3 WEEKS THEY FELT NORMAL AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS SONICARE AIRFLOSS JES PHILIPS ORAL HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O