BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAPLUS THERA-BAND NON-LATEX HEAVY DUTY BLACK

    MDR report key: 24381381 · Received February 18, 2026

    Report

    Report Number
    MW5184058
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 11, 2026
    Report Date
    February 13, 2026
    Manufacturer
    THE HYGENIC COMPANY, LLC.
    Product Code
    ION
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN OUTPATIENT PHYSICAL THERAPY SESSION, A HEAVY-DUTY THERABAND RESISTANCE BAND SNAPPED AND THE PATIENT FELL BACKWARD ONTO HER TAILBONE WITHOUT APPRECIABLE INJURY. THE RESISTANCE BAND HAD JUST BEEN REPLACED TWO WEEKS PRIOR. UPON EXAMINING THE BROKEN THERABAND, THERE WERE NO OBVIOUS DEFECTS; THE BAND APPEARS TO HAVE TORN EVENLY ACROSS WITHOUT ANY JAGGED EDGES. THE REMAINING ROLL OF THERABAND WHERE THIS PIECE WAS TAKEN FROM WAS ALSO EXAMINED WITHOUT NOTING ANY APPRECIABLE OR OBVIOUS DEFECTS. THE REMAINDER OF THE ROLL THIS BAND CAME FROM WAS DISCARDED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446007 NOVAPLUS THERA-BAND NON-LATEX HEAVY DUTY BLACK EXERCISER, NON-MEASURING ION THE HYGENIC COMPANY, LLC. P05035 REV4

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female