MAUDE Adverse Event Report: CONAIR CORP. CONAIR HEATING PAD; MASSAGING HEATING PAD

Catalog Number HP08T

Device Problem Electro-Static Discharge (2149)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 04/13/2014

Event Type  Other  

Event Description

Consumer states she rec'd burns and a shock from the thermal spa soft bath mat.She used neosporin on the burns and did not seek medical attention.

Manufacturer Narrative

The consumer would like a refund prior to returning the mat to conair.The consumer has also stated that she rec'd the massaging mat from a friend during christmas 2013, but admits that the friend owned the appliance for a while before giving it to her.The model in question was produced in the 2002-2004 era.Note that this product does not have heat or a mechanical massage.It is just a bubble mat that blows air into the water.It is uncertain how the consumer got burned.

• Brand Name: CONAIR HEATING PAD
• Type of Device: MASSAGING HEATING PAD
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902 ; 2033519000
• MDR Report Key: 3853793
• MDR Text Key: 4413600
• Report Number: 1222304-2014-00042
• Device Sequence Number: 1
• Product Code: IRT
• 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: 04/17/2014

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 Catalogue Number: HP08T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other