BEUDAMED
    FDA Adverse Event Other Summary report: N

    628A MIMYX

    MDR report key: 3288793 · Received October 17, 2007

    Report

    Report Number
    1314819-2007-01495
    Event Type
    Other
    Date Received
    October 17, 2007
    Date of Event
    September 17, 2007
    Report Date
    October 10, 2007
    Manufacturer
    STIEFEL LABORATORIES, INC.
    Product Code
    MGQ
    PMA / PMN Number
    K041342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICALLY SIGNIFICANT. PRODUCT REQUESTED TO BE RETURNED FOR TESTING. THE COMPANY PHYSICIAN SUSPECTED A RELATIONSHIP BETWEEN THE EVENTS AND MIMYX. FURTHER INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A SERIOUS, MEDICALLY SIGNIFICANT SPONTANEOUS REPORT REGARDING A (B)(6) FEMALE PATIENT WHO DEVELOPED BREATHING DIFFICULTIES/SEVERE SHORTNESS OF BREATH AND EXPERIENCED INCREASED ITCHING AFTER USING MIMYX (MIMYX). THE REPORT WAS SUBMITTED BY A CONSUMER. ON (B)(6) 2007, AT 7PM THE PATIENT USED MIMYX, APPLIED TOPICALLY FOR THE TREATMENT OF ITCHING ON ARMS AND LEGS. APPROXIMATELY 30-60 MINUTES LATER, THE PATIENT DEVELOPED BREATHING DIFFICULTIES/SEVERE SHORTNESS OF BREATH AND INCREASED ITCHING. THE PATIENT WASHED OFF THE PRODUCT (REPORTED THIS 'DID NOT HELP') AND APPLIED GOLD BOND. PATIENT TOOK A SHOWER AT 4AM - ITCHING AND SHORTNESS OF BREATH STILL PRESENT AFTER SHOWER. ON (B)(6) 2007 TREATMENT WITH MIMYX WAS DISCONTINUED. ON (B)(6) 2007 THE ITCHING RESOLVED. AT THE TIME OF THE REPORT BREATHING IS IMPROVED (ALMOST RESOLVED. DECHALLANGE: POSITIVE. PATIENT STATED DURATION WAS 'UNUSUAL'. THE PATIENT'S MEDICAL HISTORY INCLUDED: MYASTHENIA GRAVIS (DIAGNOSED IN 1987) AND HISTORY OF A SEVERE ANAPHYLACTIC REACTION TO SHELLFISH 13 YEARS AGO (TRIP TO E.R., REQUIRED EPI, LIFE-THREATENING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 628A MIMYX BARRIER CREAM MGQ STIEFEL LABORATORIES, INC. T1576

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other MULTI-VITAMINS