MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI CVS; HEATING PAD

Model Number 981-511-825

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

Consumer has not returned the product.

Event Description

Consumer alleges receiving burns on her lower back from her heating pad.There was not a report of property damage with this incident.

• Brand Name: CVS
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): ZHEIJANG LUMENG HEALTH & TECHNOLOGY CO., LTD; northwest of qunxian road and; center avenue; paojiang, 31200 ; CH 31200
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 6576680
• MDR Text Key: 75481463
• Report Number: 3010805625-2017-00117
• 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: 05/18/2017

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: 981-511-825
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other