MAUDE Adverse Event Report: HEALY GMBH HEALY; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Model Number HEALY

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  Injury  

Event Description

I purchased the healy hoping it would help me with my depression.It didn't work for me at all.I (b)(6) them yesterday and saw that their product was pulled from the market in europe.Just thought that the fda should know it is still on sale in the us.Https://www.Healyworld.Net/in/choose-your-language/.Fda safety report id # (b)(4).

• Brand Name: HEALY
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): HEALY GMBH
• MDR Report Key: 10361689
• MDR Text Key: 201767098
• Report Number: MW5095863
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HEALY
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 75