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

Model Number 981

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

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

An attorney's office is filing a court summons notice under case reference number (b)(4)alleging that a heating pad was the cause of a burn to its client's left foot and calf.There was not a report of property damage with this incident.

Manufacturer Narrative

Establishment registration #: (b)(4).Heating pad is bunched/crushed which shows abuse of the product and a violation of the instructions and warnings provided.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

An attorney's office is filing a court summons notice under case reference number (b)(4) alleging that a heating pad was the cause of a burn to its client's left foot and calf.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
• MDR Report Key: 7273799
• MDR Text Key: 100177191
• Report Number: 3010805625-2018-00034
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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: 981
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other