MAUDE Adverse Event Report: BROOKSTONE BROOKSTONE; BROOKSTONE MAX 2 DUAL NODE MASSAGER - PERSONAL MASSAGER

Model Number MAX 2 DUAL NODE MASSAGER

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 06/03/2015

Event Type  Injury  

Event Description

Incident while using personal massager, a brookstone max 2 dual node massager on his neck, consumer suffered stroke and had to be hospitalized.Retailer: (b)(6).Purchase date: (b)(6) 2014, this date is an estimate.The product was not damaged before the incident.The product was not modified before the incident.Sent information regarding injury to (b)(6).Document number: (b)(4).Report number: (b)(4).

• Brand Name: BROOKSTONE
• Type of Device: BROOKSTONE MAX 2 DUAL NODE MASSAGER - PERSONAL MASSAGER
• Manufacturer (Section D): BROOKSTONE
• MDR Report Key: 5311042
• MDR Text Key: 33995543
• Report Number: MW5058587
• Device Sequence Number: 1
• Product Code: ISA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MAX 2 DUAL NODE MASSAGER
• Type of Device Usage: N
• Patient Sequence Number: 1