MAUDE Adverse Event Report: THERAGUN, LLC THERAGUN G3PRO ; MASSAGER, THERAPEUTIC, ELECTRIC

Model Number G3PRO

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Pain (1994)

Event Date 04/05/2019

Event Type  Injury  

Event Description

I used the theragun g3pro device which seems to be a medical device at least other similar devices of the mfr are listed in the database.Using the device felt really painful and i found the user manual did not provide sufficient info when or how to use the device correctly.Fda safety report id# (b)(4).

• Brand Name: THERAGUN G3PRO
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): THERAGUN, LLC
• MDR Report Key: 8555742
• MDR Text Key: 143422807
• Report Number: MW5086210
• Device Sequence Number: 1
• Product Code: ISA
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G3PRO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR