BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYLIFE TERA P90

    MDR report key: 24832568 · Received April 9, 2026

    Report

    Report Number
    MW5186559
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    October 24, 2025
    Report Date
    April 6, 2026
    Manufacturer
    OLYLIFE INTERNATIONAL SDN BHD
    Product Code
    ISA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE PATIENTS SEEN WITH BURNS, WOUNDS AND INJURIES UTILIZING OLYLIFE TERA P90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898903 OLYLIFE TERA P90 MASSAGER, THERAPEUTIC, ELECTRIC ISA OLYLIFE INTERNATIONAL SDN BHD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization