BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH COLLECTION VIAL

    MDR report key: 1172640 · Received September 11, 2008

    Report

    Report Number
    1062336-2008-00007
    Event Type
    Other
    Date Received
    September 11, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 11, 2008
    Manufacturer
    TRIPATH IMAGING
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS CLEARLY AN UNUSUAL ACCIDENT AND USER ERROR; THERE WAS NO DEVICE MALFUNCTION. DECISION TO FILE WAS BASED ON THE FACT THAT THE PT SOUGHT MEDICAL HELP AS A RESULT OF USING THE DEVICE. IT FURTHER RELEVANT INFO BECOMES AVAILABLE, AN AMENDED REPORT WILL BE GENERATED.

    Description of Event or Problem · 1

    IN 2008, TRIPATH IMAGING TECHNICAL SUPPORT RECEIVED A REPORT FROM A PRIVATE OB/GYN CLINIC IN OTHER COUNTRY, THAT A PT MAY HAVE INGESTED SUREPATH PRESERVATIVE FLUID. THE PT PUT THE FLUID INTO HIS MOUTH, BUT SPAT OUT MOST IF NOT ALL OF IT BECAUSE OF THE TASTE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS PROVIDED TO THE CALLER. THE FLUID PRIMARILY CONTAINS DEIONIZED WATER AND ETHANOL, BUT ALSO A SMALL AMOUNT OF METHANOL (1.2%). THE VIAL IS USED TO PRESERVE A CERVICAL CYTOLOGY SAMPLE FOR ANALYSIS. IT IS NOT CLEAR HOW THE PT OBTAINED ACCESS TO THE VIAL OR IF HE ACTUALLY SWALLOWED THE CONTENTS. THE PHYSICIAN INVOLVED IN THE INCIDENT REPORTED THAT SHE CONTACTED THE PT'S MOTHER AFTER THE EVENT AND NO ADVERSE EFFECTS WERE REPORTED. NO MALFUNCTION, USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH COLLECTION VIAL CERVICAL CYTOLOGY COLLECTION VIAL LEA TRIPATH IMAGING COLLECTION VIAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other