BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 16156754 · Received January 13, 2023

    Report

    Report Number
    16156754
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    November 14, 2022
    Report Date
    December 28, 2022
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS USING HEAT PACKS FOR PAIN MANAGEMENT. PER PATIENT AS REPORTED TO NURSING LEADERSHIP THE HEAT PACK EXPLODED. CHEMICALS GOT ON HIS SKIN CREATING SOME REDNESS AND IRRITATION. THE HEAT PACK EXPLODED TO THE EXTENT OF IT BEING ON HIS BODY, PHONE, BED, AND BEDSIDE WALL BEHIND HIM. PATIENT WAS SHOWERED AND MADE SURE THAT ALL CHEMICALS WERE OFF HIS SKIN. REDNESS CONTROLLED. NO FURTHER REDNESS OBSERVED. HAVE INCLUDED CLEAN SUPPLY WHERE HEAT PACKS ARE STORED. NOT ANYWHERE NEAR HEAT SOURCE IN SUPPLY ROOM. MANUFACTURER RESPONSE FOR PACK, HOT OR COLD, DISPOSABLE, MEDICHOICE (PER SITE REPORTER) [REDACTED DATE] MATERIALS MANAGEMENT REPORTED THIS PATIENT SAFETY ISSUE TO CARDINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465310 MEDICHOICE GENERAL SURGERY TRAY LRO OWENS & MINOR DISTRIBUTION, INC. CWP954 22048454A2, 2205RA54B2

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Male