MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LTD BOSTON SCIENTIFIC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	DGP-PM2-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sustained burns under the right calf from the grounding pad.Upon closer inspection, excess hair was noted on the patients right calf which may have interfered with the pad adhering securely to the skin.It was noted that there were no prior skin injuries where the grounding pad was placed and there were no obvious creases or air bubbles when the grounding pad was applied.The grounding pad was discarded.
Event or Problem Description
It was reported that the patient sustained burns under the right calf from the grounding pad.Upon closer inspection, excess hair was noted on the patient's right calf which may have interfered with the pad adhering securely to the skin.It was noted that there were no prior skin injuries where the grounding pad was placed and there were no obvious creases or air bubbles when the grounding pad was applied.The grounding pad was discarded.Additional information was received that the patient had a second-degree burn, and the site was red with several yellow blisters.The patient was prescribed with silvadene topical ointment to be placed over the burn site and patient was taught to bandage the site.The patient was reportedly doing well.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton TQ4 7 HP; UK TQ4 7HP
• Manufacturer (Section G): CEA MEDICAL MANUFACTURING INC; 1735 merchants court; colorado springs CO 80916
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 14296675
• Report Number: 3006630150-2022-02059
• Device Sequence Number: 5524807
• Product Code: GEI
• UDI-Device Identifier: 35060441917622
• UDI-Public: 35060441917622
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/30/2023
• Device Model Number: DGP-PM2-25
• Device Catalogue Number: DGP-PM2-25
• Device Lot Number: 34299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male