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U.S. Department of Health and Human Services

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

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HEALY GMBH HEALY STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
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).
 
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Brand NameHEALY
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
HEALY GMBH
MDR Report Key10361689
MDR Text Key201767098
Report NumberMW5095863
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHEALY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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