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

Model Number	DGP-PM2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer complaint cc 1676 was received by nissha on the (b)(6) 2024 and referred to an adverse event occurring in the united states where a burn was reported to patients left thigh.Further information received on (b)(6) 2024 - initially silvadene creme was applied and given to the patient.He then went to a pcp who placed him on antibiotics, more silvadene creme, and bactroban ointment.The patient has now been referred to a wound care specialist for his burns.Since there was medical intervention, nmt has concisdered this a reportable event.
Additional Manufacturer Narrative
On receipt of the complaint all manufacturing batch records have been retrieved from archive and checks carried out as laid out below.There were no issues highlighted in the manufacturing records which could impact product quality.Pictures were provided of the burns and it is evident that hair was present on the application site.The ifu states hair must be removed prior to application and therefore this complaint can be attributed to use error.

• 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 business park; woodview rd; paington, devon, TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: jessica maureen ; 400 exchange st; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 19084692
• Report Number: 3008933393-2024-00002
• Device Sequence Number: 15380195
• Product Code: GEI
• UDI-Device Identifier: 15060441917628
• UDI-Public: (01)15060441917628(17)241016(11)221017(10)70520
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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 Expiration Date: 10/16/2024
• Device Model Number: DGP-PM2
• Device Catalogue Number: 4012996C
• Device Lot Number: 70520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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: Male