MAUDE Adverse Event Report: SHENZHEN JINYUAN SPORTS MASSAGER INSTRUMENT CO.,LT BROOKSTONE; SHIATSU 3D LUMBAR MASSAGER WITH HEAT

Model Number 882101

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

Patient Problem Not Applicable (3189)

Event Date 10/22/2015

Event Type  Injury  

Event Description

Customer alleges that she suffered a burn on her back after use of device.

• Brand Name: BROOKSTONE
• Type of Device: SHIATSU 3D LUMBAR MASSAGER WITH HEAT
• Manufacturer (Section D): SHENZHEN JINYUAN SPORTS MASSAGER INSTRUMENT CO.,LT; no 2a building, sixth industry; gongming town, baoan district; shenzhen, shenzhen guangdong 51810 6; CH 518106
• MDR Report Key: 5634304
• MDR Text Key: 44499617
• Report Number: 1221298-2016-00003
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2016

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: Other
• Device Model Number: 882101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2016
• Distributor Facility Aware Date: 01/08/2016
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other