BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RNA MEDICAL QC 253

    MDR report key: 6290026 · Received January 27, 2017

    Report

    Report Number
    MW5067554
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 27, 2017
    Manufacturer
    BIONOSTICS, INC.
    Product Code
    JJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN (B)(6), ASSUMING THAT IT WAS IN (B)(6), ONE OF THE CUSTOMERS INJURED HIMSELF WHILE OPENING ONE VIAL OF QC 253. WE RECEIVED THE REPORT FROM A SALES ASSISTANT QUALITY MANAGEMENT FROM (B)(6). SHE DID NOT RECEIVE ANY ADDITIONAL INFORMATION FROM THE PERSON INJURED DESPITE REQUEST FOR ADDITIONAL INFORMATION. WE THE MANUFACTURER, RECEIVED THE REPORT ON 01/17/2017. DIAGNOSIS OR REASON FOR USE: UNK- (B)(6) INJURED HIMSELF WHILE BREAKING THE VIAL OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67776 RNA MEDICAL QC 253 QC 253 JJS BIONOSTICS, INC. QC 253 OXY60415

    Patients

    Seq Age Sex Outcome Treatment
    1 RNA MEDICAL FULL RANGE CO-OXIMETER CONTROL.