BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROLYSTICA ENZYMATIC PRESOAK AND CLEANER

    MDR report key: 3004251 · Received December 2, 2008

    Report

    Report Number
    1937531-2008-00001
    Event Type
    Other
    Date Received
    December 2, 2008
    Date of Event
    January 7, 2008
    Report Date
    November 25, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS REGULATED BY THE (B)(4) AS A CLASS I, 510 (K) EXEMPT MEDICAL DEVICE. THE LOT NUMBER OF THE PARTICULAR PRODUCT IS NOT AVAILABLE. PT'S AGE AND WEIGHT IS NOT PROVIDED BUT THE PT IS AN ADULT EMPLOYED AT SURGERY CTR. THE CUSTOMER TOOK CLARITIN WHEN SHE RETURNED HOME FROM WORK ON THE DAY OF THE EXPOSURE. THE NEXT DAY SHE TOOK ANOTHER DOSE OF CLARITIN AND LATER RECEIVED A BENADRYL INJECTION AT AN URGENT CARE FACILITY. THE CUSTOMER REPORTED THAT FOLLOWING BENADRYL ADMINISTRATION HER SYMPTOMS CLEARED AND THERE IS NO LONG-TERM EFFECT. THE CUSTOMER NOTED THAT SHE IS HIGHLY SENSITIVE TO PERFUME. THIS PRODUCT DOES CONTAIN A FRAGRANCE BUT DOES CONTAIN A (B)(4) WHICH CAN INDUCE AN ALLERGIC RESPONSE IN SOME INDIVIDUALS. THE PRODUCT LABELING AND MATERIAL SAFETY DATA SHEET IDENTIFY THAT THE PRODUCT CONTAINS SUBTILISINS AND THAT AN ALLERGENIC RESPONSE MAY OCCUR IN SOME INDIVIDUALS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER EYE BECAME SWOLLEN DUE TO INHALATION EXPOSURE TO THIS INSTRUMENT CLEANING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLYSTICA ENZYMATIC PRESOAK AND CLEANER CLEANER, ULTRASONIC, MEDICAL INSTRUMENT FLG STERIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization