BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE

    MDR report key: 7806222 · Received August 22, 2018

    Report

    Report Number
    2024800-2018-00007
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 30, 2018
    Report Date
    August 22, 2018
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LIO
    UDI-DI
    25420045506272
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER, (B)(6), REPORTED AN INCIDENT WHERE A CHILD INGESTED AN UNKNOWN VOLUME OF APTIMA TRANSPORT MEDIA, PRIOR TO COLLECTION OF SAMPLE. THE SWAB COLLECTION TUBE CONTAINS SOLN., TRANSPORT MEDIA (PN: 101768). THE CHILD WAS GIVEN PLENTY OF WATER TO DRINK AS TREATMENT. PER THE SAFETY DATA SHEET FOR TRANSPORT MEDIA/COLLECTION DEVICES (REV. DATE 06/25/2018), THE FIRST AID MEASURE FOR INGESTION IS TO "CLEAN MOUTH WITH WATER AND DRINK AFTERWARDS PLENTY OF WATER. IF SYMPTOMS PERSIST, CALL A PHYSICIAN". IN ADDITION, THE PRODUCT CONTAINS NO SUBSTANCES, WHICH AT THEIR GIVEN CONCENTRATION, ARE CONSIDERED TO BE HAZARDOUS TO HEALTH. CUSTOMER HAS NOT CALLED BACK FOR ANY OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648906 KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE IN-VITRO DIAGNOSTIC LIO HOLOGIC, INC. 25420045506272

    Patients

    Seq Age Sex Outcome Treatment
    1 Other