BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETOUCH AVF NEEDLE

    MDR report key: 4905914 · Received July 10, 2015

    Report

    Report Number
    8041145-2015-00008
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    July 28, 2010
    Report Date
    May 1, 2015
    Manufacturer
    NIPRO THAILAND CORPORATION LTD
    Product Code
    FOZ
    PMA / PMN Number
    K032777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    INCIDENT REPORTED THAT DURING THE FIRST WEEK OF (B)(6) 2010, SOME DONORS FROM THE CENTER PLAUEN/ZWICKAU COMPLAINT ABOUT REDDISH, ITCHING NODULE, THAT LOOKED LIKE A MOSQUITO BITE, AND THAT DEVELOPED AT THE PUNCTURE SITE, BETWEEN 2 DAYS TO 3 WEEKS AFTER BLOOD DONATION. THE SKIN REACTION IS STILL VISIBLE 3 WEEKS AFTER THE DONATION. SINCE (B)(6) 2010 DRK BLUTSPENDEDIENST OST OBSERVED AN INCREASE IN THE NUMBER OF INCIDENTS. BECAUSE THEIR CENTERS IN CHEMNITZ, COTTBUS, DRESDEN AND POTSDAM DID NOT REPORT ANY CASES, DRK STARTED TO REGISTER THEM SYSTEMATICALLY. SINCE EARLY AUGUST, NEW CASES WERE OBSERVED WITH NEW NEEDLES IN ALL CENTERS. UNTIL NOW, 125 REGISTERED DONORS HAVE BEEN REPORTED WITH CHANGES TO THEIR SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449242 SAFETOUCH AVF NEEDLE AVF NEEDLE FOZ NIPRO THAILAND CORPORATION LTD AV SF1625 HC 15R ET 10B04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other