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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Pain (1994); Scar Tissue (2060); Impaired Healing (2378); Blister (4537)

Event Date 04/18/2022

Event Type  Injury  

Event Description

Using heating pad on chest while sleeping.Woke to severe pain, there was large burn water blister on my chest.Wound was very painful.Heating pad was very hot especially near where cord connects to the pad.Wound was very painful and wasn't healing well.Went to doctor on (b)(6) 2022 they put me on antibiotics and did a wound culture.Culture was negative.I have a raised scar that continues to have pain and am seeing my doctor at (b)(6) on (b)(6) 2022 to check why i am still having pain from the burn.I have pictures of burn.Fda safety report id #(b)(4).

• Brand Name: ELECTRIC HEATING PAD
• Type of Device: PAD, HEATING, POWERED
• Manufacturer (Section D): MIGHTY BLISS WHELE LLC
• MDR Report Key: 15800329
• MDR Text Key: 303801882
• Report Number: MW5113274
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic