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

Model Number	DGP-PMC2-25
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had an rfa on 8/5 and reported a burn on the back of their right thigh.Burn cream was prescribed to aid in healing.
Additional Manufacturer Narrative
A dhr review was completed for the associated lot, 80875.There were no nonconformances identified with the materials or process prior to release of the product.There have been no other complaints for this lot.Additional information was requested but was not able to be provided.With the limited information provided, no further action is required at this time.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paignton, devon TQ4 T HP; UK TQ4 THP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paignton, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: juliana scotto di carlo ; 400 exchange street; buffalo, NY 14204 ; 7168496419
• MDR Report Key: 20200620
• Report Number: 3008933393-2024-00012
• Device Sequence Number: 20501920
• Product Code: GEI
• UDI-Device Identifier: 15060441917635
• UDI-Public: (01)15060441917635(17)260111(11)240112(10)80875
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 01/11/2026
• Device Model Number: DGP-PMC2-25
• Device Catalogue Number: 4012998C
• Device Lot Number: 80875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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: Other
• Patient Sex: Unknown