MAUDE Adverse Event Report: VIKTOR JURGEN HAIR PRODUCTS VIKTOR JURGEN MASSAGE AUTOMOBILE PILLOW; MASSAGER

Device Problem Fire (1245)

Patient Problem Burn, Thermal (2530)

Event Date 04/16/2019

Event Type  Injury  

Event Description

A viktor jurgen massage lumbar pillow back support caught fire and caused damage to my wife's clothing, a slight burn to her torso and major damage to the back of the front seat.It started in the on off switch to the best of our knowledge.In over a month with communication (e-mail), no one has asked to look at the pillow.This could have been a very dangerous situation.As the fire dept said that we were lucky.The next one may not be so lucky.Mfr / importer / private labeler name: sold by (b)(6).(b)(4).

• Brand Name: VIKTOR JURGEN MASSAGE AUTOMOBILE PILLOW
• Type of Device: MASSAGER
• Manufacturer (Section D): VIKTOR JURGEN HAIR PRODUCTS
• MDR Report Key: 8679711
• MDR Text Key: 147368955
• Report Number: MW5087199
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1