MAUDE Adverse Event Report: CONAIR CORP. CONAIR MASSAGER; HEATED MASSAGER

Model Number WM25CS

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 07/04/2014

Event Type  Other  

Event Description

Consumer claims to have burned his back while using the massager.He states that the unit felt very hot after approx five minutes.When he took it from his lower back it blistered right away.Consumer claims to have third degree burns.

Manufacturer Narrative

The consumer returned the unit to the retailer from whom it was originally purchased.We have reached out to the retailer and they will be contacting us upon locating the returned product.

• Brand Name: CONAIR MASSAGER
• Type of Device: HEATED MASSAGER
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902 ; 2033519000
• MDR Report Key: 4017260
• MDR Text Key: 18291373
• Report Number: 1222304-2014-00047
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/09/2014

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: WM25CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other