BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE PATH

    MDR report key: 754300 · Received August 23, 2006

    Report

    Report Number
    1216677-2006-00014
    Event Type
    Injury
    Date Received
    August 23, 2006
    Date of Event
    June 8, 2006
    Report Date
    August 22, 2006
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPATULA IS SUPPLIED AS A COMPONENT TO TRIPATH IMAGINING FOR USE IS THE SURE PATH PRESERVATION CERVICAL SAMPLING SYSTEM. THE SPATULA IS DESIGNED TO BREAK TO FACILITATE SAMPLE COLLECTION. IN THIS USE, THE SPATULA DID NOT MALFUNCTION. NO FURTHER DETAILS OF THE EVENT ARE KNOWN. THIS REPORT MAY BE SUPPLEMENTED AS NEW INFORMATION BECOMES AVAILABLE. REGULATIONS REGARDING MDR REPORTING ARE APPLICABLE. COOPER SURGICAL BELIEVES THAT TRIPATH IMAGING HAS ALREADY SUBMITTED AN MDR ON OR ABOUT JULY 19, 2006.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL AT FACILITY SNAPPED THE HEAD OF THE SPATULA AND SOME OF THE COLLECTED MATERIAL SPLASHED IN THE HEALTHCARE PROFESSIONAL'S EYE. THE SAMPLE WAS FROM A HIV POSITIVE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE PATH PT COLLECTION KIT MKQ COOPERSURGICAL, INC. 02500-SC 49683

    Patients

    Seq Age Sex Outcome Treatment
    1