MAUDE Adverse Event Report: MASSAGE CHAIR; MASSAGER, THERAPEUTIC, ELECTRIC

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

Patient Problems High Blood Pressure/ Hypertension (1908); Vascular System (Circulation), Impaired (2572)

Event Date 10/01/2018

Event Type  Injury  

Event Description

Massage chair changed circulation caused hypertension, owners would not give return call about the name of the product at (b)(6).The management, owners from (b)(6) has not given responses about the name of their massage chairs.It appears to me my heart rate changed to the pace of the chair leg compressions.A couple of years they did not give response after request for them to give my cardiology office the information about the chairs to compare test.I have hypertension, to normal blood pressure with asymmetrical posture, circulation problems.Fda safety report id # (b)(4).

• Brand Name: MASSAGE CHAIR
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• MDR Report Key: 10118796
• MDR Text Key: 194162331
• Report Number: MW5094840
• 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: Patient
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• 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 Outcome(s): Disability
• Patient Age: 45 YR
• Patient Weight: 67