BEUDAMED
    FDA Adverse Event Other Summary report: N

    AURSTAT ANTI-ITCH HYDROGEL 225 ML

    MDR report key: 4001620 · Received June 20, 2014

    Report

    Report Number
    3005856705-2014-00001
    Event Type
    Other
    Date Received
    June 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    PURICORE INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STROKE (CEREBROVASCULAR ACCIDENT), HEADACHE (HEADACHE), HEAVINESS OR DIZZINESS IN HEAD (DIZZINESS). ON (B)(6) 2014, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER REGARDING AN (B)(6) FEMALE OF CAUCASIAN ETHNICITY WHO WAS BEING TREATED WITH AURSTAT ANTI-ITCH HYDROGEL 225 ML. MED HISTORY INCLUDED A HEART STENT, HIGH BLOOD PRESSURE, AND ECZEMA. CONCOMITANT PRODUCTS INCLUDED CLOBETASOL CREAM, COZAAR (LOSARTAN POTASSIUM), AND PROTONIX (PANTOPRAZOLE SODIUM). DATES OF THERAPY WERE NOT REPORTED. ON (B)(6) 2014, THE PATIENT STARTED TREATMENT WITH AURSTAT ANTI ITCH HYDROGEL 2205 ML, APPLYING A LITTLE BIT ON HER HANDS AND SPREADING IT ONTO HER ARMS, BACK, LEGS, AND STOMACH TWICE DAILY (AFTER A SHOWER AND AT NIGHT, 15 MINUTES PRIOR TO APPLYING CLOBETASOL CREAM) FOR ECZEMA. ON (B)(6) MAY 2014, 15 TO 20 MINUTES AFTER APPLYING THE PRODUCT, THE PATIENT EXPERIENCED HEADACHE AND "HEAVINESS" OR DIZZINESS IN HER HEAD. THE EVENTS LASTED 40 TO 45 MINUTES AND THEN RESOLVED. ON(B)(6) 2014, THE PATIENT CALLED HER PHYSICIAN'S OFFICE AND SPOKE WITH A PHYSICIAN ASSISTANT (PA-C) WITH WHOM SHE WAS UNFAMILIAR. THE PHYSICIAN ASSISTANT DIDN'T THINK THERE WAS A RELATIONSHIP BETWEEN THE PRODUCT AND THE SYMPTOMS, BUT SHE DID THINK THE PATIENT HAD EXPERIENCED A STROKE. NO ADDITIONAL TREATMENT OR EVAL WAS PROVIDED. AS OF (B)(6) 2014, PRODUCT USE CONTINUED AND THE DURATION OF HER SYMPTOMS HAD DECREASED EVERY DAY SINCE SHE STARTED THE PRODUCT. ON THE MORNING OF (B)(6) 2014, HER SYMPTOMS ONLY LASTED 5 MINUTES. NO ADDITIONAL INFO WAS PROVIDED AND THE REPORTER DECLINED TO PROVIDE PERMISSION TO CONTACT A HEALTH CARE PROFESSIONAL MOST FAMILIAR WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364336 AURSTAT ANTI-ITCH HYDROGEL 225 ML FRO PURICORE INC. P3491513A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other COZAAR| CLOBETASOL CREAM| PRAVASTATIN| HYDROCHLOROTHIAZIDE| PROTONIX