BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIOS/STS SINGLE CHEST PAD

    MDR report key: 8902938 · Received August 16, 2019

    Report

    Report Number
    2921578-2019-00029
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    March 1, 2019
    Report Date
    February 27, 2020
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430106026
    Adverse Event
    Yes
    Product Problem
    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

    IT WAS REPORTED THAT MULTIPLE OCCURRENCES OF REDNESS/SKIN BREAKDOWN ON PATIENTS UNDERGOING PRONE SURGERY DURING (B)(6) 2019 TO (B)(6) 2019. SECOND MDR 2921578-2019-00030 WAS CREATED TO REPORT THE SECOND PATIENT, AS THIS EVENT OCCURRED ON AT LEAST 2 PATIENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THEY WERE TILTING THE TABLE, THE TABLE SLIPPED WHICH CAUSED THE PATIENT TO FALL OFF THE TABLE. PATIENT WAS NOT STRAPPED TO THE TABLE TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695015 TRIOS/STS SINGLE CHEST PAD PAD JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5840-7569 00842430106026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other