MAUDE Adverse Event Report: UNKNOWN THERAGUN MASSAGER; MASSAGER, THERAPEUTIC, ELECTRIC

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 04/29/2023

Event Type  Injury  

Event Description

51 year old male with a muscle spasm of his neck suffered a vertebral artery dissection after his wife used a theragun massager on his neck.The vertebral artery dissection resulted in an embolic stroke.

• Brand Name: THERAGUN MASSAGER
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16888612
• MDR Text Key: 314884576
• Report Number: MW5117368
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2023

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Life Threatening; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White