BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDCARE SURFACE DISINFECTANT

    MDR report key: 2983620 · Received February 28, 2013

    Report

    Report Number
    1722021-2013-00001
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    METREX RESEARCH
    Product Code
    LRJ
    PMA / PMN Number
    K951123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPLOYEE SOUGHT MEDICAL ATTENTION FROM A GENERAL PRACTITIONER WITH REGARD TO HER ITCHY THROAT; THE DOCTOR DIAGNOSED HER WITH ACID REFLUX AND PRESCRIBED HER OMEPRAZOLE. WHEN THE SYMPTOMS CONTINUED, THE EMPLOYEE OBTAINED A REFERRAL FROM THE GENERAL PRACTITIONER AND WENT TO SEE AN EAR, NOSE, AND THROAT SPECIALIST; THE ENT DOCTOR PRESCRIBED HER FLONASE. DURING A FOLLOW UP PHONE CALL ON (B)(4) 2013, THE EMPLOYEE REPORTED THAT SINCE SHE BEGAN UTILIZING PROPER PROTECTIVE EQUIPMENT WHEN SPRAYING THE PDCARE SURFACE DISINFECTANT PRODUCT SHE IS FEELING BETTER; HOWEVER, THE SYMPTOMS HAVE NOT COMPLETELY SUBSIDED AT THIS TIME. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS TESTED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS; THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS AND ACCEPTABLE PARAMETERS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    AN EMPLOYEE ALLEGED THAT SHE HAS BEEN EXPERIENCING A REACTION WITH THE SYMPTOM OF AN ITCHY THROAT BOTH AT WORK AND WHILE AT HOME FOR APPROXIMATELY ONE (1) YEAR WHICH SHE FEELS MAY BE LINKED TO THE USE OF PDCARE SURFACE DISINFECTANT. THE EMPLOYEE ALSO REPORTED COUGHING WHEN SPRAYING THE PDCARE SURFACE DISINFECTANT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86158 PDCARE SURFACE DISINFECTANT DISINFECTANT, MEDICAL DEVICES LRJ METREX RESEARCH 12-2264

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R