BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARDIAN MINI SLIDE STRIP HYDROCOLLOID 2007

    MDR report key: 22509884 · Received July 15, 2025

    Report

    Report Number
    MW5172681
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A 14 DAY HOLTER MONITOR TEST AND USED A BODYGUARDIAN MINI WITH STRIPS. I USED THE SENSITIVE SKIN STRIPS "HYDRDOCOLLOID 2007" REF (B)(4) LOT 846250 MFG DATE 12/17/24 GOOD THRU 12/17/26. BOSTON SCIENTIFIC CARDIAC WAS THE ISSUER IN ROCHESTER, MN AND EMERGO EUROPE IS THE MANUFACTURER. THE FIRST TIME I CHANGED THE STRIP, EVEN WITH GOING VERY SLOW WITH HOT WATER IT LEFT BLISTERS. WHEN I REMOVED THE STRIP AND DEVICE ON THE FINAL DAY, IT ALMOST GAVE ME A SKIN TEAR, BUT LEFT A ITCHING/BURNING RASH WITH PUSTULES- EXTREMELY PAINFUL. I WAS SEEN BY A WALK IN CLINIC THEY THOUGHT DERMATITIS. IT IS NOW 7/10 AND I HAVE A PERMANENT SCAR- ALMOST LIKE A BURN MARK FROM WHERE THE DEVICE AND STRIPS WERE. I DID REPORT THIS TO BOSTON SCIENTIFIC. I HAVE PICTURES OF MY SKIN AFTERWARDS SAVED; I ALSO HAVE SOME OF THE STRIPS LEFT IN CASE YOU NEED THEM. SOMETHING IS VERY WRONG WITH THESE STRIPS- THEY¿RE SUPPOSEDLY FOR SENSITIVE SKIN BUT THEY IRRITATE YOUR SKIN, WHEN I FIRST TOOK IT OFF IT BURNED AND LOOKED LIKE A BAD SUNBURN- LIKE I SAID MONTHS LATER I NOW REALIZE IT DID LITERALLY BURN ME, AND I NOW HAVE A PERMANENT SCAR THANKS TO THIS FAULTY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151983 BODYGUARDIAN MINI SLIDE STRIP HYDROCOLLOID 2007 ELECTRODE, ELECTROCARDIOGRAPH DRX BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC B46250

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other AMBIEN.| AMLODIPINE.| IBUPROFEN AS NEEDED.| VITAMIN B12.| XANAX.