BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS

    MDR report key: 22456390 · Received July 9, 2025

    Report

    Report Number
    22456390
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 20, 2025
    Manufacturer
    MEDIVANCE, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT 1 [DATE REDACTED]: RN OPENED BRAND NEW ARCTIC SUN PAD, AND THE ADHESIVE COVER WAS NOT ON THE PAD CORRECTLY. THE STICKY MATERIAL WAS DEFECTIVE. PRODUCT NOT OK FOR USE. RN BROUGHT TO OFFICE, SAVED PACKAGING. MEDIUM ARCTIC GEL PAD. REF 317-07, LOT NGKP2765. 2027-01-31. MEDIVANCE EVENT 2 [DATE REDACTED]: ARCTIC SUN PAD DEFECTIVE. RN OPENED PACKAGE OF ARCTIC SUN PAD, AND THE ADHESIVE LAYER COMPLETELY CAME OFF OF THE PAD WHEN THE FILM WAS REMOVED. SECOND TIME THIS HAS BEEN FOUND. PRODUCT DETAILS: MEDIUM ARCTIC GEL PAD, REF 317-07, LOT NGKP2765, 2027-01-3. MEDIVANCE INC. PRODUCT IN OFFICE FOR PICKUP. [DATE REDACTED] SAMPLE COLLECTED. [DATE REDACTED] EMAILED [REDACTED]. MANUFACTURER RESPONSE FOR ARCTIC SUN PAD, ARCTIC SUN PAD (PER SITE REPORTER). SITE CONTACTED REP FOR PRODUCT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119825 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS SYSTEM, THERMAL REGULATING DWJ MEDIVANCE, INC. 31707 NGKP2765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown