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

Model Number MNV730

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

There is an instruction that states, "this pad is not to be used on or by an invalid, a sleeping or unconscious person, a person with diabetes, or a person with poor blood circulation or insensitivity to heat, or a person incapacitated by medication" and consumer failed to perform that instruction.There is an instruction that states, "burns can occur regardless of control setting, check skin under pad frequently" and consumer failed to perform that instruction.

Event Description

Consumer alleges using her heating pad on her sofa while clothed and received burns on her abdomen.There was not a report of property damage with this incident.

Manufacturer Narrative

There is an instruction that states, "this pad is not to be used on or by an invalid, a sleeping or unconscious person, a person with diabetes, or a person with poor blood circulation or insensitivity to heat, or a person incapacitated by medication" and consumer failed to perform that instruction.There is an instruction that states, "burns can occur regardless of control setting, check skin under pad frequently" and consumer failed to perform that instruction.Heating pad is bunched/ which shows abuse of the product and a violation of the instructions and warnings provided.

Event Description

Consumer alleges using her heating pad on her sofa while clothed and received burns on her abdomen.There was not a report of property damage 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, 236 ; TW 236
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 7429088
• MDR Text Key: 105415310
• Report Number: 3007790958-2018-00063
• 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,Followup
• Report Date: 05/01/2018

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: MNV730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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