BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARDIAN MINI PLUS LITE

    MDR report key: 25140044 · Received May 11, 2026

    Report

    Report Number
    MW5187940
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
    Product Code
    MLN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS PRESCRIBED A 30-DAY CARDIAC MONITORING DEVICE FROM BOSTON SCIENTIFIC CARDIAC DIAGNOSTICS. THE DEVICE MALFUNCTIONED REPEATEDLY AND ONLY RECORDED APPROXIMATELY 9 DAYS OF DATA BEFORE FAILING. THE LEFT SIDE OF THE DEVICE BLINKED RED AND STOPPED RECORDING. I CONTACTED BOSTON SCIENTIFIC MULTIPLE TIMES ((B)(6) 2026, (B)(6) 2026, (B)(6) 2026) TO REPORT THE MALFUNCTION. ON (B)(6) 2026, I WAS INSTRUCTED TO REMOVE THE DEVICE AFTER 25 MINUTES. ON (B)(6) 2026, MY DOCTOR INSTRUCTED ME TO RETURN THE DEVICE DUE TO CONTINUED FAILURE. THE ADHESIVE ALSO CAUSED A BURN INJURY TO MY CHEST, WHICH REQUIRED MEDICAL ATTENTION. I HAVE PHOTOS AND MEDICAL DOCUMENTATION CONFIRMING THE INJURY. BECAUSE THE DEVICE FAILED, THE 30-DAY STUDY WAS INCOMPLETE AND MEDICALLY INSUFFICIENT. DEVICE TIMELINE AND USE DETAILS: I RECEIVED THE FIRST CARDIAC MONITOR KIT FROM MY DOCTOR'S OFFICE WITH THE "SENSITIVE SKIN" ADHESIVE. I BEGAN USING IT, BUT I DEVELOPED A SKIN REACTION AND BURNING. THE DEVICE ALSO BEGAN MALFUNCTIONING. BOSTON SCIENTIFIC INSTRUCTED ME TO STOP USING THE FIRST ADHESIVE AROUND (B)(6) 2026 DUE TO THE REACTION AND MALFUNCTION. BOSTON SCIENTIFIC THEN SENT ME A REPLACEMENT ADHESIVE THAT THEY STATED IS NORMALLY USED FOR INFANTS. I RECEIVED THIS REPLACEMENT AROUND (B)(6) 2026. I ATTEMPTED TO USE THE NEW ADHESIVE THREE TIMES. THE LAST USE WAS ON (B)(6) 2026, BUT THE BURNING AND SKIN IRRITATION BECAME SEVERE AGAIN. MY DOCTOR ADVISED ME TO STOP USING THE DEVICE AND RETURN IT ON (B)(6) 2026 DUE TO THE CONTINUED SKIN REACTION AND DEVICE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611032 BODYGUARDIAN MINI PLUS LITE ELECTRODE, ELECTROCARDIOGRAPH, MULTI-FUNCTION MLN BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other| R ACETAMINOPHEN.| ALBUTEROL INHALER.| AMLODIPINE.| ASPIRIN.| ASPIRIN.| BENEFIBER.| BISMUTH SUBSALICYLATE.| CELECOXIB.| CLOBETASOL OINTMENT.| CLOPIDOGREL.| CLOTRIMAZOLE CREAM.| DEXCOM G7 SENSOR.| ELINZANETANT.| FAMOTIDINE.| FEZOLINETANT.| GLUCOSE TEST STRIPS.| HYOSCYAMINE.| INSULIN DEGLUDEC.| INSULIN LISPRO.| LIDOCAINE OINTMENT.| MAGNESIUM HYDROXIDE.| METHOCARBAMOL.| METOPROLOL.| NYSTATIN POWDER.| ONDANSETRON ODT.| PANTOPRAZOLE. | PAROXETINE| PEN NEEDLES.| PREGABALIN.| ROSUVASTATIN.| SENNA-DOCUSATE.| SODIUM PHOSPHATE ENEMA.| SUMATRIPTAN.| TERCONAZOLE CREAM.| TIRZEPATIDE.| TRAMADOL.