BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERICE / NORMATEC

    MDR report key: 21078640 · Received January 6, 2025

    Report

    Report Number
    3003619590-2024-00005
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    September 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 Occupation
    OTHER

    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

    THE CUSTOMER APPROACHED A NORMATEC FOUNDER AT AN EVENT AND REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK) A FAMILY MEMBER ALERTED THEM THAT THERE WAS SMOKE COMING FROM THE DEVICE. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURRED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE REPORTED DAMAGE WAS TO THE BATTERY PACK, WHICH HOUSES A LITHIUM-ION BATTERY SUPPLIED BY (B)(4)., A THIRD-PARTY SUPPLIER THAT HYPERICE NO LONGER USES FOR BATTERIES. NO DAMAGE TO THE DEVICE ITSELF WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351292 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