BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS PCR FEMALE SWAB KIT

    MDR report key: 7128094 · Received December 19, 2017

    Report

    Report Number
    2243471-2017-00025
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 19, 2017
    Manufacturer
    STACIE-ANN CREIGHTON
    Product Code
    MKZ
    PMA / PMN Number
    K110923
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE FOR COBAS PCR FEMALE SWAB KIT PROVIDES THE CONTENTS OF THE COBAS PCR MEDIA (= 40% (W/W) GUANIDINE HYDROCHLORIDE; TRIS-HCL BUFFER) AND INDICATES THAT THE MEDIA IS HARMFUL IF SWALLOWED AND ADVISES THAT IF SWALLOWED TO CALL A POISON CENTER OR DOCTOR/ PHYSICIAN IF FEELING UNWELL. THE SAFETY DATA SHEET FOR THE COBAS PCR MEDIA PROVIDES THE SAME INSTRUCTIONS AS THE INSTRUCTIONS FOR USE, AS WELL AS INDICATES TO RINSE MOUTH WITH WATER IF SWALLOWED AND DRINK PLENTY OF WATER AFTERWARDS. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION REGARDING THE CHILD'S STATE OF HEALTH OR TREATMENT INFORMATION WILL BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED THAT A CHILD INGESTED COBAS PCR MEDIA (PACKAGED WITHIN THE COBAS PCR FEMALE SWAB KIT) AT THEIR FACILITY. IT WAS REPORTED THAT THE CHILD WAS VOMITING AS A RESULT OF INGESTING THE COBAS PCR MEDIA. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED REGARDING THE STATE OF THE HEALTH OF THE CHILD OR WHETHER TREATMENT WAS PROVIDED. THE CUSTOMER INDICATED THEY ADVISED THAT THE CHILD'S PARENT CALL POISON CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910019 COBAS PCR FEMALE SWAB KIT DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA, MKZ STACIE-ANN CREIGHTON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other