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

Model Number 538

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Consumer admits to laying on the heating pad which is abuse of the product and a violation of the instructions and warnings provided.Consumer did not return the product.

Event Description

Consumer states she was using a heating pad on her hip while laying in a recliner.She is alleging that her heating pad burned a hole in her recliner and a sheet.There was not a report of injury with this incident.

• Brand Name: SUNBEAM
• 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): SKY EAGLE HOLDINGS CORP.; no. 128,chung hwa rd.,sec. 2,; taipei hsien, china (taiwan) 236 ; TW 236
• Manufacturer Contact: tracie jones ; p.o. box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 6102464
• MDR Text Key: 59891018
• Report Number: 3007790958-2016-00178
• 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: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 538
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1