MAUDE Adverse Event Report: CONAIR LLC. CONAIR; MASSAGER

Model Number BM1RLF

Device Problem Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - the consumer accepted an replacement product and will not return the original product to the manufacturer for an investigation.

Event Description

On (b)(6) 2022 - the consumer claims the controller started to smoke.The consumer accepted a replacement.

• Brand Name: CONAIR
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR LLC.; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 14285813
• MDR Text Key: 299587614
• Report Number: 1222304-2022-00013
• Device Sequence Number: 1
• Product Code: ISA
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BM1RLF
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other