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

Model Number NA-H 11218

Device Problems Overheating of Device (1437); Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Was told unit over heats and sparks.Fda safety report id #(b)(4).

• Brand Name: HEATING PAD
• Type of Device: PAD, HEATING, POWERED
• Manufacturer (Section D): WHELE LLC
• MDR Report Key: 15690752
• MDR Text Key: 302782537
• Report Number: MW5112950
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NA-H 11218
• Device Catalogue Number: THRU AMAZON
• Device Lot Number: 210801
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: TOO MANY TO LIST. HEART BLOOD PRESSURE, CHOLESTEROL, INSULIN, GOUT.; VITA C, E, D, POTASSIUM, MAGNESIUM.
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White