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

Model Number HP15RB

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Date 03/09/2014

Event Type  Injury  

Manufacturer Narrative

Device is currently being evaluated.A supplemental report will be submitted upon completion of the investigation.

Event Description

Consumer feel asleep on her heating pad and woke up to feel her back burning.After further investigation, she noticed the heating pad burned through the plastic and the heating pad cover, as well as her pillow, pillow case and mattress pad.

• Brand Name: CONAIR CORP
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 3763310
• MDR Text Key: 21167802
• Report Number: 1222304-2014-00039
• 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: 04/01/2014

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: Other
• Device Model Number: HP15RB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 03/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR