BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCARE PLUS

    MDR report key: 1695283 · Received May 20, 2010

    Report

    Report Number
    1937531-2010-00002
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 20, 2010
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTOR OF OCCUPATIONAL HEALTH AT (B)(6) HOSPITAL CONTACTED STERIS TO OBTAIN INFORMATION ON THE STERIS PRODUCT ALCARE PLUS AND POTENTIAL FOR THE PRODUCT TO CAUSE A RESPIRATORY ALLERGENIC RESPONSE. THE DIRECTOR WAS INFORMED THAT STERIS DOES NOT HAVE A HISTORY OF THIS PRODUCT CAUSING THIS TYPE OF ALLERGENIC RESPONSE, THAT THE PRODUCT DID NOT CONTAIN INGREDIENTS THAT SHOW A HISTORY OF THIS TYPE OF RESPONSE, THE INGREDIENTS ARE ALL LISTED ON THE LABEL, AND STERIS IS NOT IN A POSITION TO TELL THE COMPLAINANT THAT OUR PRODUCT COULD NOT BE THE CAUSE OF HER SYMPTOMS. STERIS SUGGESTED THE COMPLAINANT CONSULT WITH AN ALLERGIST TO DETERMINE THE CAUSE. THE DIRECTOR OF OCCUPATIONAL HEALTH INFORMED STERIS THAT THE EMPLOYEE WAS AN RN IN THE CARDIOVASCULAR ICU EMPLOYED BY (B)(6) FOR 3 YEARS; THE EMPLOYEE DOES NOT CURRENTLY USE THE PRODUCT, BUT HAD USED THE PRODUCT IN THE PAST AND IS CONVINCED THAT THE USE OF ALCARE PLUS BY OTHERS EVEN AT A DISTANCE OF 30 FEET AWAY IS CAUSING HER RESPIRATORY PROBLEMS. SHE HAS NOT SOUGHT ANY MEDICAL TREATMENT/INTERVENTION AND CLAIMS SHE SUFFERED FROM "ENVIRONMENTAL COUGHING" AT A PREVIOUS EMPLOYER IN (B)(6), BUT DID NOT CONSULT WITH AN ALLERGIST AND BELIEVES HER SYMPTOMS MAY HAVE BEEN CAUSED BY A FLOOR STRIPPER. SHE CLAIMS HER SYMPTOMS SHOWED IN (B)(6) 2009 AND IS SHARING HER COMPLAINT FOR THE FIRST TIME NOW. THE DIRECTOR OF OCCUPATIONAL HEALTH STATED "THAT SHE IS NOT CONVINCED THAT THE EMPLOYEE IS ALLERGIC TO ALCARE PLUS; INFORMED THE EMPLOYEE THAT (B)(6) WAS UNWILLING TO COMPLY WITH THE REQUEST OF THE REMOVAL OF ALCARE PLUS FROM THE WORK AREA; ADVISED THE EMPLOYEE TO SEEK CONSULTATION WITH AN ALLERGIST AS SOON AS POSSIBLE AND PROVIDED A COPY OF THE MSDS TO THE EMPLOYEE". A COPY OF THE PRODUCT LABEL WAS ALSO PROVIDED TO THE DIRECTOR OF OCCUPATIONAL HEALTH.

    Description of Event or Problem · 1

    A WORKMAN'S COMPENSATION CASE INVOLVING A PRIOR EMPLOYEE OF (B)(6) HOSPITAL IN (B)(6) HAS BEEN FILED. THE EMPLOYEE CLAIMS THAT EXPOSURE TO THE STERIS HANDWASH PRODUCT ALCARE PLUS, AN OTC DRUG, CAUSED HER TO EXPERIENCE A RESPIRATORY REACTION, I.E. ASTHMA-LIKE SYMPTOMS. THE EMPLOYEE REPORTS THAT SHE HAS BEEN HOSPITALIZED SEVERAL TIMES FOR THESE SYMPTOMS. TREATMENT IS UNKNOWN. EVIDENCE OF ALCARE PLUS AS THE CAUSATIVE AGENT IS UNKNOWN. THE EMPLOYEE INFORMED STERIS THAT THE ORIGINAL ADVERSE EVENT OCCURRED IN 2009. STERIS WILL PROVIDE ADDITIONAL UPDATES SHOULD THEY BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCARE PLUS HEALTHCARE PERSONNEL HANDWASH LRJ STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other