MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; NEUTRAL ELECTRODES GROUDING PAD

Lot Number 2308242401

Device Problems Thermal Decomposition of Device (1071); Unintended Magnet Quench (1377); Folded (2630)

Patient Problems Burn(s) (1757); Injury (2348); No Information (3190)

Event Date 11/27/2023

Event Type  Injury  

Event Description

Grounding pad was removed and burn was noted on pt's skin.

• Brand Name: MEGADYNE
• Type of Device: NEUTRAL ELECTRODES GROUDING PAD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state street; draper UT 84020
• MDR Report Key: 18495935
• MDR Text Key: 332689338
• Report Number: 18495935
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2308242401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2023
• Date Report to Manufacturer: 12/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR