BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROCHAMBER WITH MASK, MEDIUM

    MDR report key: 345927 · Received August 2, 2001

    Report

    Report Number
    1317346-2001-00002
    Event Type
    Malfunction
    Date Received
    August 2, 2001
    Date of Event
    March 11, 2001
    Report Date
    August 2, 2001
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    CAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A REPORT CONCERNING A PT WHO EXPERIENCED COUGHING, WHEEZING AND AN OXYGEN PERCENTAGE OF 88% TO 92% WHILE BEING TREATED WITH AEROCHAMBER WITH MASK (MEDIUM) FOR ASTHMA. ACCORDING TO THE FAMILY MEMBER, THE FAMILY MEMBER GAVE THE PT A BREATHING TREATMENT IN 2001 WITH THE AID OF A NEW AEROCHAMBER WITH MASK (MEDIUM). THE PT CONTINUED TO COUGH, AND BEGAN WHEEZING. THE FAMILY MEMBER TOOK THE PT TO THE EMERGENCY ROOM, WHERE A PULSE OXIMETER SHOWED AN OXYGEN PERCENTAGE BETWEEN 88% AND 92%. THE PT WAS RELEASED WITHOUT TREATMENT, BUT WAS BROUGHT BACK LATER THAT SAME DAY, AND SEEN BY A DIFFERENT ER DOCTOR. THE PULSE OXIMETER READING WAS 88%. A CHEST X-RAY WAS NEGATIVE. THE PT WAS GIVEN AN INJECTION OF "5% STEROID" AND A NEBULIZER TREATMENT OF ALBUTEROL, AND THEN RELEASED. TWO DAYS LATER, THE COUGH AND WHEEZING GOT WORSE. THE FAMILY MEMBER GAVE AN ALBUTEROL TREATMENT WHILE HOLDING THE FAMILY MEMBER'S FINGER OVER A HOLE IN THE MASK. THE FAMILY MEMBER CALLED THE PHARMACY AND THEY TOLD THE FAMILY MEMBER THAT THERE SHOULD HAVE BEEN A VALVE THERE. THE PT WAS ALSO GIVEN A VICKS VAPOR PATCH DURING THE SAME TIME. NO FURTHER INFO WAS PROVIDED. OUTCOMES ATTRIBUTED TO EVENT: NO INDICATION OF OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34690 AEROCHAMBER WITH MASK, MEDIUM AEROSOL HOLDING CHAMBER CAF MONAGHAN MEDICAL CORP. NA 1758-01

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other