MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; MASSAGER

Model Number WM50FF

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2021 - the consumer requested a replacement device and does not want a claim submitted.Therefore the device will not be returned and an investigation will not take place.

Event Description

On (b)(6) 2021 - the consumer has submitted this incident on behalf of this wife.The consumer claims the product caught on fire and his wife received a burn.The incident occurred over a year ago and the consumer does not want to file a claim but wants a replacement.

• Brand Name: CONAIR
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 11560698
• MDR Text Key: 241977162
• Report Number: 1222304-2021-00012
• Device Sequence Number: 1
• Product Code: MNW
• 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: Other
• Type of Report: Initial
• Report Date: 03/10/2021

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: No Information
• Device Model Number: WM50FF
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR