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

Model Number DGP-PM2

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 01/30/2024

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 339876137
• Report Number: 3008933393-2024-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 15060441917628
• UDI-Public: (01)15060441917628(17)241016(11)221017(10)70520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DGP-PM2
• Device Catalogue Number: 4012996C
• Device Lot Number: 70520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male