MAUDE Adverse Event Report: WHELE LLC. MIGHTY BLISS HEATING PAD 12X24"; PAD, HEATING, POWERED

Model Number NA-H21B

Device Problems Thermal Decomposition of Device (1071); Material Frayed (1262)

Patient Problems Electric Shock (2554); Superficial (First Degree) Burn (2685)

Event Date 10/25/2022

Event Type  Injury  

Event Description

Mighty bliss heating pad lot # 200902 electric shock upon touching cord near temperature adjustment.Cord became frayed and burned.Superficial skin burns on wrist where product was picked up.Fda safety report id # (b)(4).

• Brand Name: MIGHTY BLISS HEATING PAD 12X24"
• Type of Device: PAD, HEATING, POWERED
• Manufacturer (Section D): WHELE LLC.
• MDR Report Key: 15690539
• MDR Text Key: 302764385
• Report Number: MW5112926
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/25/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA-H21B
• Device Lot Number: 200902
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2022
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Prefer Not To Disclose