BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPEUTIC BOOT

    MDR report key: 24039781 · Received January 12, 2026

    Report

    Report Number
    MW5182037
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    December 8, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BREG, INC.
    Product Code
    ITW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT A PRODUCT ISSUE AND ADVERSE EVENT INVOLVING A BREG THERAPEUTIC BOOT HE BEGAN WEARING IN EARLY DECEMBER DUE TO A LEFT 5TH METATARSAL FRACTURE. PATIENT STATED HE WAS INSTRUCTED TO WEAR THE BOOT FOR 8 WEEKS AND THAT THE BOOT WAS AMBIDEXTROUS DESIGNED TO BE WORN ON EITHER THE RIGHT OR LEFT FOOT WITH ARCH SUPPORT ON BOTH SIDES. PATIENT STATED DUE TO THE DESIGN, AND THE ARCH SUPPORT BEING ON BOTH SIDES, IT PRESSED UPON HIS 5TH METATARSAL CAUSING HIM TERRIBLE PAIN AND FURTHER SEPARATION THAN WHEN HE BEGAN WEARING THE BOOT. PATIENT SAID AFTER WEARING THE BOOT FOR 4 WEEKS AND MAKING HIS FRACTURE WORSE HE SAW HIS DOCTOR WHO REMOVED THE FOAM ARCH SUPPORT PADDING WITH A SCALPEL ON THE SIDE OF THE BOOT THAT WAS CAUSING PRESSURE AND THE PAIN STOPPED. PATIENT STATED WHILE HE HOPES THE FRACTURE WILL HEAL PROPERLY NOW, HE WAS TOLD HE MAY NEED SURGERY TO CORRECT THE SEPARATION THAT OCCURRED DURING THE FIRST 4 WEEKS OF WEARING THE BOOT DUE TO THE FOAM PADDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108771 THERAPEUTIC BOOT JOINT, ANKLE, EXTERNAL BRACE ITW BREG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention