MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; MASSAGER

Model Number BM1RLF

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2021 - the consumer accepted a replacement product and will not be returning the product to the manufacturer for an investigation.

Event Description

(b)(6) 2021 - the consumer claims the remote on the product had an electrical smell and the remote on the unit burned.The consumer accepted 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 06614
• MDR Report Key: 12128785
• MDR Text Key: 262635786
• Report Number: 1222304-2021-00019
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108061072
• UDI-Public: 74108061072
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BM1RLF
• Was Device Available for Evaluation?: No
• 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