MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LTD NEUT. ELECT, SELF-ADHESIVE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0406-650-205

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : discarded by customer.

Event Description

It was reported that the patient was burned by the grounding pad, the burn was noticed when the pad was removed.This was a 3rd degree burn and was treated with medicine and a bandage by the doctor.The procedure was completed successfully without any delays taking place.

Event Description

It was reported that the patient was burned by the grounding pad, the burn was noticed when the pad was removed.This was a 3rd degree burn and was treated with medicine and a bandage by the doctor.The procedure was completed successfully without any delays taking place.

Manufacturer Narrative

Additional information, quality investigation complete.H3 other text : discarded by customer.

• Brand Name: NEUT. ELECT, SELF-ADHESIVE
• Type of Device: 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): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17108949
• MDR Text Key: 316978806
• Report Number: 3015967359-2023-01260
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 35060842920023
• UDI-Public: 35060842920023
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2023,10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0406-650-205
• Device Lot Number: 068958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2023
• Device Age: 1 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/23/2023
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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