BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPORTNEB

    MDR report key: 528979 · Received May 23, 2004

    Report

    Report Number
    MW1032181
    Event Type
    Injury
    Date Received
    May 23, 2004
    Date of Event
    January 30, 2004
    Report Date
    May 23, 2004
    Manufacturer
    MEDICAL INDUSTRIES AMERICA INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT PURCHASED THE DRUG ALBUTEROL 2.5MG AND IPRATROPIUMO.5MG AND A NEBULIZER COMPRESSOR IN 2004. THE MEDICINE PROVED UNSATISFACTORY AND IS BELIEVED BELOW FDA STANDARDS. NO EXPIRATION DATE OR MFR IS SHOWN ON THE MEDICINE VIALS. SOME VIALS WERE COMPLETELY EMPTY AND OTHERS WERE HALF EMPTY. AFTER FIRST MONTHS USAGE DEVELOPED SYMPTOMS THAT INDICATED THE MEDICINE WAS NOT OF PROPER STRENGTH CONTRIBUTING TO PHYSICAL DEGENERATION THAT REQUIRED A VISIT TO THE DR WHO ORDERED A PRESCRIPTION TO BE FILLED BY A NEW SUPPLIER. THE NEW PRESCRIPTION OF PROPER STRENGTH RESULTED IN IMPROVEMENT IN PHYSICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPORTNEB OXYGEN CONCENTRATOR CAF MEDICAL INDUSTRIES AMERICA INC. SPORTNEB *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization