BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEP 6 SPECTRUMORANGE PROBE (ASR)

    MDR report key: 2968741 · Received February 19, 2013

    Report

    Report Number
    3005248192-2013-00004
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MVU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MATERIAL SAFETY DATA SHEET FOR DNA PROBE IN TE BUFFER ((B)(4)) INCLUDES THE FOLLOWING RECOMMENDATIONS: FIRST AID MEASURES - GENERAL INFORMATION: NO SPECIFIC MEASURES REQUIRED. - AFTER EYE CONTACT: RINSE OPENED EYE FOR SEVERAL MINUTES UNDER RUNNING WATER. EXPOSURE CONTROLS AND PERSONAL PROTECTION: - PERSONAL PROTECTIVE EQUIPMENT: GENERAL PROTECTIVE AND HYGIENIC MEASURES: THE USUAL PRECAUTIONARY MEASURES SHOULD BE ADHERED TO GENERAL RULES FOR HANDLING CHEMICALS. - EYE PROTECTION: SAFETY GLASSES RECOMMENDED DURING REFILLING. TOXICOLOGICAL INFORMATION - ACUTE TOXICITY: - LD/LC50 VALUES THAT ARE RELEVANT FOR CLASSIFICATION: NO DATA AVAILABLE FOR THIS PRODUCT. PRIMARY IRRITANT EFFECT: - ON THE EYE: NO IRRITANT EFFECT. USER ERROR.

    Description of Event or Problem · 1

    AS A CUSTOMER WAS PROCESSING SPECIMEN SLIDES SHE REMOVED THE COVERSLIP TO ELIMINATE A BUBBLE AND CEP 6 SPECTRUMORANGE PROBE SPLASHED INTO HER EYE. A SPLASH IN A MUCOUS MEMBRANE WITH PROBE AND POTENTIALLY INFECTIOUS PATIENT SAMPLE COULD RESULT IN SERIOUS INJURY. THE CUSTOMER WAS NOT WEARING SAFETY GLASSES.THE CUSTOMER FLUSHED HER EYE WITH WATER IN ACCORDANCE WITH THE LAB'S PROCEDURE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71972 CEP 6 SPECTRUMORANGE PROBE (ASR) ANALYTE SPECIFIC REAGENTS, PRODUCT CODE: MVU MVU ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other