MAUDE Adverse Event Report: SMART CIRCLE INTERNATIONAL WWW.S SONIC CARE PERSONAL MASSAGER

Model Number 133804A

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/25/2016

Event Type  Injury  

Event Description

Husband was using sonic comfort personal massager and suffered large 1st degree burns on his back, requiring him to seek medical care within 2 hours.The product brochure inside did not come with instructions, nor safety warning.He was treated at a walk in clinic with silver nitrate ointment.

• Brand Name: SONIC CARE PERSONAL MASSAGER
• Type of Device: MASSAGER
• Manufacturer (Section D): SMART CIRCLE INTERNATIONAL WWW.S
• MDR Report Key: 5640723
• MDR Text Key: 44835374
• Report Number: MW5062139
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 00846362074293
• UDI-Public: 846362074293
• 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: 05/05/2016

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: Lay User/Patient
• Device Model Number: 133804A
• Device Lot Number: 1653040 27415
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 100