BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE OXIMETRY SENSOR

    MDR report key: 17516422 · Received August 11, 2023

    Report

    Report Number
    MW5123371
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    March 9, 2017
    Manufacturer
    STRYKER CORP
    Product Code
    DQA
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER SERVES TO INFORM THE AGENCY OF A COMPLAINT RECEIVED BY GE HEALTHCARE ON MARCH 3, 2017 AGAINST A MEDICAL DEVICE THAT IS NOT MANUFACTURED, DISTRIBUTED, OR IMPORTED BY GE HEALTHCARE. THE CUSTOMER STATES A PATIENT EXPERIENCED A BURN TO THE LEFT FIRST DIGIT FINGER IN THE SAME LOCATION AS AN SPO2 SENSOR. THE CUSTOMER IDENTIFIED THE PULSE OXIMETRY SENSOR AS A RECYCLED STRYKER MODEL MAX A PROBE, LOT#4981173. THE AREA OF CONCERN WAS DESCRIBED AS A CIRCULAR, WHITE DISCOLORATION TO THE ANTERIOR TIP OF THE LEFT FIRST DIGIT MEASURING APPROXIMATELY 5MM. IT IS UNKNOWN IF MEDICAL TREATMENT WAS REQUIRED RELATED TO THIS EVENT. THE GE HEALTHCARE MANUFACTURED DEVICE TO WHICH THE PULSE OXIMETRY SENSOR WAS ATTACHED WAS TESTED AND NO ISSUES WERE FOUND; THERE IS NO INDICATION OF A GE HEALTHCARE DEVICE MALFUNCTION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117460 PULSE OXIMETRY SENSOR OXIMETER DQA STRYKER CORP 4981173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown