BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUSON

    MDR report key: 2820870 · Received October 29, 2012

    Report

    Report Number
    3009498591-2012-00011
    Event Type
    Other
    Date Received
    October 29, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 29, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    ITX
    PMA / PMN Number
    K081148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE CUT HER FINGER AGAINST A SHARP EDGE ON THE INSIDE OF THE ABVS POD BOTTOM HOUSING, HOWEVER, THE WOUND DID NOT NECESSITATE MEDICAL TREATMENT BEYOND BASIC FIRST AID. PER HEAD OF QUALITY AND TECHNOLOGY FOR (B)(6), THIS INCIDENT IS REPORTABLE TO THE (B)(6) WITHIN 30 DAYS FROM THE AWARENESS DATE (B)(6) 2012 AS A POTENTIAL RISK FOR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSON DIAGNOSTIC ULTRASOUND DEVICE ITX SIEMENS MEDICAL SOLUTIONS USA, INC. ABVS-BASE BOM

    Patients

    Seq Age Sex Outcome Treatment
    1