MAUDE Adverse Event Report: NES HEALTH LTD. NES MIHEALTH; DEVICE, BIOFEEDBACK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Tachycardia (2095); Sleep Dysfunction (2517)

Event Date 07/30/2020

Event Type  Injury  

Event Description

I was instructed to place an electrical over my heart for the purpose to clear energy blockages.Later in the day/ evening i experienced an elevated heart rate for an extended period of time.I told the practitioner and she stated it sounded to her like i was experiencing a detox effect.My elevated heart rate kept me up all night and i had many trips to the bathroom because my colon was being stimulated by this.The practitioner knew i have crohns.I repeatedly told her i am not suppose to do anything that would stimulate my colon.This device also masks symptoms.I was unable to tell how my medication was working.This device has way of making a person feel rejuvenated and energetic.Some people may even choose to forgo medical care because of this feeling this device can cause.Fda safety report id# (b)(4).

• Brand Name: NES MIHEALTH
• Type of Device: DEVICE, BIOFEEDBACK
• Manufacturer (Section D): NES HEALTH LTD.
• MDR Report Key: 10521192
• MDR Text Key: 206834186
• Report Number: MW5096556
• Device Sequence Number: 1
• Product Code: HCC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 59