MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; FOOTBATHS

Model Number FB90

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020 - the consumer discarded the product and accepted a refund.Therefore an investigation will not occur.

Event Description

On (b)(6) 2020 - the consumer claims the product smoked and smelled like fire.The consumer discarded the product and accepted a refund.

• Brand Name: CONAIR
• Type of Device: FOOTBATHS
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford 06902
• MDR Report Key: 11027579
• MDR Text Key: 222696042
• Report Number: 1222304-2020-00034
• Device Sequence Number: 1
• Product Code: IMC
• UDI-Device Identifier: 74108396860
• UDI-Public: 74108396860
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FB90
• Was Device Evaluated by Manufacturer?: 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: 60 YR