BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 25252980 · Received May 22, 2026

    Report

    Report Number
    3009096682-2026-00006
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A PATIENT WHO STATED THAT THEIR CPAP NOSE MASK WAS ¿CAUSING A SEVERE RASH OR ACNE.¿ NO FURTHER DETAILS WERE PROVIDED. ADDITIONALLY, THE PATIENT DID NOT PROVIDE ANY INFORMATION REGARDING THE MASK BEING USED. AS A RESULT, SECTION D4 (MODEL NUMBER, CATALOG NUMBER, LOT NUMBER AND UDI NUMBER) AND SECTION D1 (BRAND NAME) ARE "UNKNOWN". 3B MEDICAL INC HAS MADE MULTIPLE ATTEMPTS THROUGH EMAIL (NO PHONE NUMBER WAS PROVIDED), TO CONTACT THE PATIENT IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE REPORTED ISSUE, NOR DID THE PATIENT STATE THAT ANY MEDICAL INTERVENTION/TREATMENT WAS NECESSARY. 3B MEDICAL, INC. IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. THE PATIENT CONTACTED 3B MEDICAL INC DIRECTLY, AS A RESULT, SECTION E1 NAME, ADDRESS AND PHONE ARE ALL NA TO PROTECT THEIR PRIVACY. THE MASK HAS NOT BEEN RETURNED TO 3B MEDICAL INC OR THE MANUFACTURER FOR AN EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68375 UNKNOWN VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male