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 Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

Discarded by customer.

Event Description

It was reported that the patient received a burn at the grounding pad site, it was noted that grounding pad gel had dried.The procedure was completed successfully with no delays or medical intervention.A topical cream was used to treat the burn and prevent infection.

Event Description

It was reported that the patient received a burn at the grounding pad site, it was noted that grounding pad gel had dried.The procedure was completed successfully with no delays or medical intervention.A topical cream was used to treat the burn and prevent infection.

Manufacturer Narrative

Follow-up report submitted to document device evaluation results.

• 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: 15931122
• MDR Text Key: 307177436
• Report Number: 3015967359-2022-02400
• 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,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406-650-205
• Device Lot Number: 202401BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2022
• 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