BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERICE / NORMATEC

    MDR report key: 21078642 · Received January 6, 2025

    Report

    Report Number
    3003619590-2024-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    June 25, 2024
    Report Date
    December 26, 2024
    Manufacturer
    NORMATEC INDUSTRIES, LP
    Product Code
    IRP
    UDI-DI
    00810050281997
    PMA / PMN Number
    K220217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS MANUFACTURED BY A CONTRACT MANUFACTURER, RYDER ELECTRONICS (XINFENG) LTD., LOCATED AT EAST SHUIDONG AVENUE, INDUSTRIAL PARK, XINFENG TOWN, GANZHOU CITY JIANGXI, CN 341600. WHILE AWAITING SET-UP OF ITS ELECTRONIC SUBMISSIONS GATEWAY, HYPERICE ATTEMPTED TO SUBMIT THIS REPORT VIA EMAIL TO [email protected] ON DECEMBER 26, 2024.

    Description of Event or Problem · 0

    HYPERICE WAS NOTIFIED ABOUT A FIRE AT A PHYSICAL THERAPY CLINIC BY THE CLINIC'S INSURANCE CARRIER. THE DEVICE IS BEING EVALUATED AMONG MULTIPLE POTENTIAL CAUSES FOR THE FIRE. HYPERICE HAS REQUESTED ADDITIONAL INFORMATION FROM THE CLINIC AND ITS INSURER IN ORDER TO INVESTIGATE WHETHER A MALFUNCTION OCCURRED, BUT IT DOES NOT HAVE MORE DETAIL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359831 HYPERICE / NORMATEC POWERED INFLATABLE TUBE MASSAGER IRP NORMATEC INDUSTRIES, LP MODEL REJ6 BATTERY LOT # 20211124 00810050281997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown