MAUDE Adverse Event Report: WHELE, LLC. MIGHTY BLISS HEATING PAD; PAD, HEATING, POWERED

Model Number NA-H1121B

Device Problem Nonstandard Device (1420)

Patient Problems Hemorrhage/Bleeding (1888); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Being disabled, i used heating pad for relief without realizing until it had burned my back to the point of bleeding and blistering.I have major depression disorder and didn't care at the time to report issue, but after receiving information from amazon regarding recall and dangers, i am making sure to inform the proper authorities regarding this matter.Fda safety report id # (b)(4).

• Brand Name: MIGHTY BLISS HEATING PAD
• Type of Device: PAD, HEATING, POWERED
• Manufacturer (Section D): WHELE, LLC.
• MDR Report Key: 15690611
• MDR Text Key: 302768307
• Report Number: MW5112932
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA-H1121B
• Device Lot Number: 210402
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White