BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER URINE COLLECTION C&S CUP KIT

    MDR report key: 4217519 · Received October 22, 2014

    Report

    Report Number
    2243072-2014-00267
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BD
    Product Code
    JTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAME IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCLUSION: WITHOUT A SAMPLE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AFTER USING THE CASTILE TOWELETTE FROM THE BD VACUTAINER URINE COLLECTION C&S CUP KIT, SHE DEVELOPED AN ALLERGIC REACTION IN HER GENITOURINARY AREA. THE PT IS TREATING THE AFFECTED AREA WITH NYSTATIN CREAM PRESCRIBED BY A PHYSICIAN AND IS ALSO WASHING THE AFFECTED AREA WITH VINEGAR AND WATER TO RELIEVE HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674215 BD VACUTAINER URINE COLLECTION C&S CUP KIT URINE C&S CUP KIT JTW BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention