MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NEUT. ELECT, SELF-ADHESIVE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0406-650-205

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported by the sales rep that the patient received a burn at the grounding pad site during a procedure.The procedure was completed successfully with no delays.The patient came in 4 weeks late for a follow up and was referred to the wound care clinic for treatment on the burn.We have reached out to the customer to see about obtaining additional details about the event.

Manufacturer Narrative

H3 other text : discarded by customer.

• Brand Name: NEUT. ELECT, SELF-ADHESIVE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16961484
• MDR Text Key: 315553544
• Report Number: 3015967359-2023-01136
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 35060842920023
• UDI-Public: 35060842920023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406-650-205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• 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