BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOWAVE CORP.

    MDR report key: 24680018 · Received March 24, 2026

    Report

    Report Number
    3004558433-2026-00001
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 11, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BIOWAVE CORP.
    Product Code
    GXY
    UDI-DI
    00859911006232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS CONFIRMED TO BE FUNCTIONING AS DESIGNED. NO MANUFACTURING ANOMALIES WERE IDENTIFIED REVIEW OF THE CURRENT QUICK REFERENCE GUIDE (QRG, REV 5) CONFIRMS THAT THE LABELING SPECIFICALLY DIRECTS PATIENTS TO APPLY BIOWAVE THERACREAM CONDUCTIVE CREAM AS THE SOLE CONDUCTIVE MEDIUM PRIOR TO DEVICE USE. THERACREAM IS REFERENCED CONSISTENTLY THROUGHOUT THE DIRECTIONS FOR USE AND TROUBLESHOOTING SECTIONS, AND IS INCLUDED IN THE PRODUCT PACKAGE. HOWEVER, THE QRG DOES NOT CONTAIN AN EXPLICIT WARNING AGAINST THE USE OF ALTERNATIVE TOPICAL PRODUCTS, SPRAYS, OR CREAMS IN CONJUNCTION WITH THE DEVICE. THE CONTRAINDICATIONS SECTION DOES NOT ADDRESS THE USE OF NON-INDICATED TOPICAL SUBSTANCES. AS A RESULT, WHILE THERACREAM USE WAS SPECIFIED, THE HAZARD OF USING ALTERNATIVE TOPICAL PRODUCTS WAS NOT ADEQUATELY COMMUNICATED TO PATIENTS OR CLINICIANS, AND WAS NOT IDENTIFIED AS A RISK IN THE DEVICE RISK MANAGEMENT FILE. PLANNED CORRECTIVE ACTIONS:1. UPDATE IFU TO INCLUDE EXPLICIT WARNINGS AGAINST USE OF TOPICAL SPRAYS, LOTIONS, OR CREAMS IN CONJUNCTION WITH THE DEVICE2. UPDATE RISK MANAGEMENT FILE TO INCLUDE IDENTIFIED HAZARD AND ASSOCIATED RISK CONTROLS3. ISSUE COMMUNICATION TO CLINICIANS REGARDING CONTRAINDICATION.

    Description of Event or Problem · 0

    PATIENT REPORTED DEVELOPMENT OF BLISTERS ON SKIN FOLLOWING USE OF BIOWRAP SILVER BACK, AN ELECTRODE GARMENT WRAP. PRIOR TO USE, PATIENT APPLIED A TOPICAL SPRAY (CIGNA SPRAY ) TO THE SKIN, WHICH WAS RECOMMENDED BY THEIR TREATING CLINICIAN. PATIENT DEVELOPED BLISTERS AT THE SITE OF DEVICE CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742106 BIOWAVE CORP. SILVER BIOWRAPS GXY BIOWAVE CORP. BWRPSILVER-BACK-SM 033180 00859911006232

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other