MAUDE Adverse Event Report: CONAIR CORP. CONAIR; FOOT BATH

Model Number FB39W

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2013

Event Type  Other  

Event Description

Consumer claims that the foot bath leaked and ruined her rug.

• Brand Name: CONAIR
• Type of Device: FOOT BATH
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902 ; 2033519000
• MDR Report Key: 3652880
• MDR Text Key: 21731541
• Report Number: 1222304-2014-00018
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FB39W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1