BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRESERVATIVE FLUID

    MDR report key: 1622210 · Received March 1, 2010

    Report

    Report Number
    1062336-2010-00001
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 1, 2010
    Manufacturer
    TRIPATH IMAGING
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE MALFUNCTION. THE EXPOSURE OF THE PATIENT TO HER OWN PAP SAMPLE WAS ACCIDENTAL. CLINICIAN TOOK FIRST AID MEASURES THAT INCLUDED RINSING MOUTH WITH WATER AND KEEPING PATIENT IN OFFICE FOR EXTRA PERIOD OF TIME (20 MINUTES). THE PATIENT HAS REPORTED NO SYMPTOMS AND ADDITIONAL MEDICAL TREATMENT WAS NOT REQUIRED. A COPY OF THE MSDS FOR THE PRESERVATIVE FLUID WAS FAXED TO CLINICIAN. DECISION TO FILE WAS BASED ON EXPOSURE OF A MUCOSAL SURFACE TO THE PRESERVATIVE FLUID WITH PATIENT SAMPLE. BASIC FIRST AID WAS REQUIRED.

    Description of Event or Problem · 1

    A PAP SAMPLE WAS COLLECTED BY CLINICIAN FROM A PATIENT AND THE PATIENT WAS EXPOSED TO THE COLLECTED SAMPLE. THE CLINICIAN INDICATED THAT PATIENT SPLASHED SUREPATH PRESERVATIVE FLUID ON THEIR MOUTH. THE PATIENT DID NOT INGEST THE FLUID WITH SAMPLE. BASIC FIRST AID INCLUDING RINSING THE PATIENT'S MOUTH AND DRINKING A LARGE GLASS OF WATER WAS GIVEN. NO FURTHER MEDICAL TREATMENT WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR PROBLEMS AS A RESULT OF THE EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRESERVATIVE FLUID SUREPATH COLLECTION VIAL MKQ TRIPATH IMAGING COLLECTION VIAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other