MAUDE Adverse Event Report: CONMED UTICA EXACTRACE 5-PACK,FOAM LOW PROF W/WET GEL (600/CS); ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 1510-005

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A device history record review cannot be conducted since the lot number is unknown.A lot history review cannot be conducted since the lot number is unknown.A two-year review of complaint history revealed there has been a total of 22 complaints, regarding 24 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that the electrode site should be dry before electrode application.Fluids, including skin cleaning solutions, lotions or soapy water may cause skin irritation and loss of adhesion.Keep electrode site dry.The ifu also advises the user to apply wet gel electrodes to the skin and gently press down around the outer edge of electrode in a circular motion to assure firm attachment to the skin.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (mw5102275) on 23jul21.The current complaint database has been researched for this event and there were no findings.The report was found to be written against the 1510-005, stating a few patients received burns around the electrode site.Patients are doing well, reporting purposes only.The medwatch received indicates the report type to be serious injury.The medwatch report did not indicate who the reporter was; therefore, we contacted the fda and were advised that the reporter requested anonymity.No further information is available.This report is being raised on the basis of injury due to a report of burns without degree of burn indicated.

• Brand Name: EXACTRACE 5-PACK,FOAM LOW PROF W/WET GEL (600/CS)
• Type of Device: 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: 12385780
• MDR Text Key: 271665387
• Report Number: 1320894-2021-00336
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K963787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1510-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1