MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LIMITED BOSTON SCIENTIFIC; NEUTRAL ELECTRODE

Model Number	DGP-PMC2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 17th april 2023 the uk facility has received a customer complaint from the customer boston scientific regarding: - it was reported that: grounding pad burn, burned two patients one yesterday, (b)(6) 2023 and one today, (b)(6) 2023, grounding pads used nikmed pad by bsc reference 2407 yesterday, (b)(6) 2023 bsc neuturo nonwired.Additional information was received that patient was treated with bacitracin antibiotic ointment and dry bandage.This record is for the patient burned on (b)(6) 2023.No lot number provided.Due to medical intervention, nmt finds this event to be reportable.
Additional Manufacturer Narrative
No lot number provided.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paington, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay bussiness park; woodview rd; paington, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: jessica potter ; 400 exchange st; buffalo, NY 14127 ; 7168496367
• MDR Report Key: 16855870
• Report Number: 3008933393-2023-00010
• Device Sequence Number: 15169929
• Product Code: GEI
• UDI-Device Identifier: 15060441917642
• UDI-Public: 15060441917642
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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: Health Professional
• Device Model Number: DGP-PMC2
• Device Catalogue Number: 4012998C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown