MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. SUNBEAM; HEATING PAD

Model Number 749

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Consumer claims he was using a heating pad on his back and allegedly received a burn that became infected.

Manufacturer Narrative

The pad has been requested from the consumer to determine if the incident arose from abuse/misuse of the pad (i.E.Bunching/folding /crushing).A prepaid label was sent to the consumer for return of the product.Consumer has not returned the product.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center dr.; dba jarden consumer solutions; boca raton FL
• Manufacturer (Section G): SKY EAGLE HOLDINGS CORP.; eagle electric shenshen; no. 128, chung hwa. sec. 2 tucheg; taipei, hsien 236 ; TW 236
• Manufacturer Contact: tracie jones ; p.o. box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3716172
• MDR Text Key: 19970641
• Report Number: 3007790958-2014-00053
• 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: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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