MAUDE Adverse Event Report: CONAIR LLC. CONAIR; MASSAGER

Model Number THM001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

4/6/2024 - the consumer claims the product smelt like it was burning.The consumer accepted a replacement as the product was under warrantly and will not provide to the manufacturer for an investigation.

Manufacturer Narrative

4/6/2024 - the consumer accepted a replacement and will not return the device to the manufacturer for an investigation.

• 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: 19056598
• MDR Text Key: 340459195
• Report Number: 1222304-2024-00007
• 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: Other
• Type of Report: Initial
• Report Date: 04/06/2024

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: THM001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other