BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIOS/STS SINGLE CHEST PAD

    MDR report key: 8903252 · Received August 16, 2019

    Report

    Report Number
    2921578-2019-00030
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 25, 2019
    Report Date
    February 27, 2020
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING DISCUSSION WITH NURSE REVEALED NO CASES OF SKIN BREAKDOWN - ONLY INITIAL REDNESS WHICH RESOLVED POSTOPERATIVELY. LONG CONTACT WITH THE CHEST PAD WITHOUT RELIEVING PRESSURE MAY CAUSE REDNESS. THIS USUALLY RESOLVES ITSELF, AS WAS THE CASE WITH REPORTED EVENT.

    Description of Event or Problem · 0

    MULTIPLE OCCURRENCES OF REDNESS/SKIN BREAKDOWN ON PATIENTS UNDERGOING PRONE SURGERY DURING (B)(6) 2019. THIS IS REPORTED TO HAVE OCCURRED ON APPROXIMATELY 2-4 PATIENTS DURING THIS TIMEFRAME. (FIRST PATIENT REPORTED IN MDR 2921578-2019-00032).

    Description of Event or Problem · 1

    MULTIPLE OCCURRENCES OF REDNESS/SKIN BREAKDOWN ON PATIENTS UNDERGOING PRONE SURGERY DURING (B)(6) 2019 - (B)(6) 2019. THIS IS REPORTED TO HAVE OCCURRED ON APPROXIMATELY 2-4 PATIENTS DURING THIS TIMEFRAME. (FIRST PATIENT REPORTED IN MDR 2921578-2019-00029) NO INFORMATION ABOUT THE SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697021 TRIOS/STS SINGLE CHEST PAD PAD JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5840-7569

    Patients

    Seq Age Sex Outcome Treatment
    1 Other