MAUDE Adverse Event Report: CONAIR LLC. CONAIR; PARRAFIN BATH

Model Number PB8

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2022 - since the consumer did not provide their name or address, we are unable to contact the consumer to request the device be returned to the manufacturer.Therefore, an investigation will not be completed.

Event Description

On (b)(6) 2022 - the consumer claims the product gets to hot.The consumer did not provide their name or mailing address.Therefore we will not be receiving the product for an investigation or it's unknown if the consumer received a replacement.

• Brand Name: CONAIR
• Type of Device: PARRAFIN BATH
• Manufacturer (Section D): CONAIR LLC.; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 15182238
• MDR Text Key: 305000573
• Report Number: 1222304-2022-00031
• Device Sequence Number: 1
• Product Code: IMC
• UDI-Device Identifier: 74108260468
• UDI-Public: 74108260468
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PB8
• 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
• Patient Outcome(s): Other