MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ULTRACLEAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	139110EXT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the 139110ext, accessory electrode coated blade w/extended insulation device was used in an unnamed procedure on approximately (b)(6) 2025, and "this bovie burnt the patient under doctors use.".Further assessment was attempted, and a good faith effort was made to obtain additional information; however, no response has been received to date.This report is being raised due to the reported injury of a burn of unknown degree to the patient.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised the following: use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.Never allow the cables connected to these devices to be in contact with skin of the patient or operator during electrosurgical activations.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the 139110ext, accessory electrode coated blade w/extended insulation device was used in an unnamed procedure on approximately on (b)(6) 2025, and "this bovie burnt the patient under doctors use." further assessment was attempted, and a good faith effort was made to obtain additional information; however, no response has been received to date.This report is being raised due to the reported injury of a burn of unknown degree to the patient.

• Brand Name: ULTRACLEAN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22174672
• Report Number: 3007305485-2025-00099
• Device Sequence Number: 7829510
• Product Code: GEI
• UDI-Device Identifier: 40653405007341
• UDI-Public: (01)40653405007341(17)281021(10)202310235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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 Catalogue Number: 139110EXT
• Device Lot Number: 202310235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic