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

Model Number HP08T

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/07/2014

Event Type  No Answer Provided  

Event Description

(b)(6) advised us on behalf of (b)(6) that the consumer reports that a heating pad damaged her recliner.

Manufacturer Narrative

An investigation is currently being conducted for all hp08 heating pads.A supplementary report will be submitted upon completion of the investigation.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 3763469
• MDR Text Key: 18361674
• Report Number: 1222304-2014-00030
• 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: Other
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HP08T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other