BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCOAG DESTINY MAX

    MDR report key: 4935337 · Received July 21, 2015

    Report

    Report Number
    2245451-2015-00003
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 20, 2015
    Manufacturer
    TCOAG DEUTSCHLAND GMBH
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED DIAGNOSTICA STAGO INC. ON (B)(6) 2015 TO REPORT AN INCIDENT THAT OCCURRED ON (B)(4) 2015 IN WHICH ONE OF THE TECHNOLOGISTS WAS PUNCTURED BY THE CAP PIERCING NEEDLE ON THE DEVICE DURING ROUTINE MAINTENANCE. ACCORDING TO THE INCIDENT REPORT SUPPLIED BY THE CUSTOMER: THE EMPLOYEE WAS TREATED AT THE OCCUPATIONAL HEALTH CLINIC AT (B)(4) HOSPITAL AFTER A SAMPLE PROBE STICK WHILE PERFORMING INSTRUMENT MAINTENANCE. SHE WAS GIVEN A T-DAP SHOT, (B)(4) BOOSTER, ROUTINE BLOOD WORK AND A 28 DAY TREATMENT OF (B)(6) PROPHYLAXIS (TRUVADA AND RALTEGRAVIR). MFR. # 3003943960-2015-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473171 TCOAG DESTINY MAX DESTINY MAX JPA TCOAG DEUTSCHLAND GMBH M01000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention