MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; FOOTBATH

Model Number FB70WP19

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

On 12/16/2019 - we requested the device be returned to the manufacturer for an evaluation.To date we have not received the device.

Event Description

On (b)(6) 2019 - the consumer claims that the product caught on fire and burnt a whole in her carpet.Injuries did not occur.

• Brand Name: CONAIR CORPORATION
• Type of Device: FOOTBATH
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 9480480
• MDR Text Key: 176946631
• Report Number: 1222304-2019-00029
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 74108343017
• UDI-Public: 74108343017
• Combination Product (y/n): N
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: FB70WP19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• 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: 47 YR