MAUDE Adverse Event Report: CONMED UTICA CLEARTRACE;5;TP,ADGEL; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number	1700-005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Blister (4537)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 1700-005, cleartrace;5;tp,adgel, was used for unknown reason on (b)(6) 2024 when it was reported, ¿patient had an allergic reaction, full blister the circumference of the electrode.Blisters ended up oozing after she took the electrodes off.They do not believe that she made it 6 hours with them on, but are unsure.".There was no report of medical intervention or hospitalization for the patient.There has not been any allegation of malfunction of the device to date.This report is being raised due to the reported injury of allergic reaction/blistering to the patient.
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 for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot 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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: the electrode site should be dry before electrode application.Fluids, including skin cleansing solution, lotions or soapy water may cause skin irritation and loss of adhesion.Keep electrode site dry.In rare instances, alteration of the skin pigmentation or skin sensitization may occur after electrode removal.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 1700-005, cleartrace;5;tp,adgel, was used for unknown reason on (b)(6) 2024 when it was reported, ¿patient had an allergic reaction, full blister the circumference of the electrode.Blisters ended up oozing after she took the electrodes off.They do not believe that she made it 6 hours with them on, but are unsure.".There was no report of medical intervention or hospitalization for the patient.There has not been any allegation of malfunction of the device to date.This report is being raised due to the reported injury of allergic reaction/blistering to the patient.

• Brand Name: CLEARTRACE;5;TP,ADGEL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18920404
• Report Number: 1320894-2024-00068
• Device Sequence Number: 6130795
• Product Code: DRX
• UDI-Device Identifier: 10653405004240
• UDI-Public: (01)10653405004240(17)250618(10)202306191
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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 Expiration Date: 06/18/2025
• Device Catalogue Number: 1700-005
• Device Lot Number: 202306191
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic