BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMARA VIEW MASK

    MDR report key: 15939086 · Received December 8, 2022

    Report

    Report Number
    2518422-2022-101267
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 25, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    BZD
    PMA / PMN Number
    K082866
    Removal / Correction Number
    RES90705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION FROM AN END USER ALLEGING FROM THE USAGE OF HIS AMARA VIEW FULL MASK AND HEADGEAR WITH MAGNETS, HIS HEARING-IMPAIRED WIFE (DEAFNESS) IS NOW EXPERIENCING STRONG STRENGTH IN HER RIGHT EAR AND IS SUFFERING FROM STOMACH PROBLEMS. THERE WAS NO FURTHER INFORMATION AVAILABLE AS TO WHAT TYPE, IF ANY, IMPLANT THE WIFE MAY BE USING. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-101267 AS A PRODUCT PROBLEM ONLY. AFTER FURTHER REVIEW FROM THE MANUFACTURER, THERE IS SUFFICIENT EVIDENCE TO PRONOUNCE THIS AS A SERIOUS INJURY AS WELL AS DEFINED IN PEPF 16.2.8.3 AND 21 CFR 803.3(W). THE MANUFACTURER HAS UPDATED SECTIONS B1, B2, AND H1 IN THIS REPORT. THE PATIENT OUTCOME CODE GRID AND HEALTH IMPACT GRID WERE CORRECT ON THE PREVIOUS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM AN END USER ALLEGING FROM THE USAGE OF HIS AMARA VIEW FULL MASK AND HEADGEAR WITH MAGNETS, HIS HEARING-IMPAIRED WIFE (DEAFNESS) IS NOW EXPERIENCING STRONG STRENGTH IN HER RIGHT EAR AND IS SUFFERING FROM STOMACH PROBLEMS. THERE WAS NO FURTHER INFORMATION AVAILABLE AS TO WHAT TYPE, IF ANY, IMPLANT THE WIFE MAY BE USING. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585514 AMARA VIEW MASK VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other