MAUDE Adverse Event Report: CONAIR CORP CONAIR CORP; PARAFFIN BATH

Model Number JBPB10C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Tingling (2171)

Event Date 03/10/2014

Event Type  No Answer Provided  

Event Description

Consumer claims that she placed her feet in the wax and immediately felt her feet burning.She removed her feet from the unit and after drying them she put burn ointment on the bottoms.Her feet are still tingling.

Manufacturer Narrative

Complaint is currently being evaluated.Product is being investigated and a supplemental report will be submitted upon completion of the investigation.

• Brand Name: CONAIR CORP
• Type of Device: PARAFFIN BATH
• Manufacturer (Section D): CONAIR CORP; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 3763467
• MDR Text Key: 19295084
• Report Number: 1222304-2014-00037
• Device Sequence Number: 1
• Product Code: IMC
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: JBPB10C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1