MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; MASSAGER

Model Number NM8

Device Problem Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

10/19/2021 - the consumer claims the device was sparking in the area by the cord.The consumer has accepted a replacement device.

Manufacturer Narrative

11/10/2021 - the consumer accepted a replacement product.Therefore the product will not be submitted to the manufacturer for an investigation.

• 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: 12786032
• MDR Text Key: 282225116
• Report Number: 1222304-2021-00030
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108098986
• UDI-Public: 74108098986
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NM8
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1