BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QCARE Q2 DEGREE ORAL CLEANSING AND SUCTIONING SYSTEM

    MDR report key: 2463771 · Received February 14, 2012

    Report

    Report Number
    1419181-2012-00001
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    July 10, 2011
    Report Date
    January 27, 2012
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    EIA
    PMA / PMN Number
    K901806
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT ON (B)(6) 2011, SHE SUCTIONED A PT'S "BLOODY" MOUTH USING A SAGE SUCTION SWAB. REPORTEDLY, THE PT WAS (B)(6). AFTER SUCTIONING WAS COMPLETED, SHE STATED SHE DISCONNECTED THE SUCTION SWAB FROM THE SUCTION LINE WHEN SHE WAS SPLASHED IN THE LEFT EYE WITH THE PT'S SECRETIONS. SHE STATED SHE FLUSHED HER EYE WITH WATER AND WENT TO THE EMERGENCY ROOM. SHE WAS PRESCRIBED A (B)(6) REGIMEN OF TWO MEDICATIONS WHICH SHE STATED SHE COMPLETED. REPORTER INDICATED SHE DID NOT KNOW WHAT CAUSED THE EVENT TO OCCUR. IT WAS REPORTED THAT ALTHOUGH FACILITY PROTOCOL DICTATED USE OF SAFETY GOGGLES, SHE WAS NOT WEARING EYE PROTECTION AT THE TIME OF EVENT. REPORTEDLY, THE SUCTION SWAB WAS DISCARDED. LOT INFO WAS NOT AVAILABLE FROM REPORTER. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QCARE Q2 DEGREE ORAL CLEANSING AND SUCTIONING SYSTEM SUCTION SWAB EIA SAGE PRODUCTS, INC. 6412 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SUCTION SOURCE| SUCTION TUBING