MAUDE Adverse Event Report: CONMED CORPORATION PROFILE TAPE ELECTRODE, 50; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 2500-050

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 12/22/2019

Event Type  Injury  

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 2500-050, was being used during an mri brain scan and mri lumber spine on (b)(6) 2019.The device has been placed by the er.Approximately on (b)(6) 2020 the patient produced a picture showing 2-irregular round, white marks on their chest.The exact date that the patient first made claim of receiving "burns" from the device during the mri is unknown.Per the reporter, in or around 13feb2020, a letter was sent requesting pictures; however, there was no response from the patient and no photos were produced at that time.The degree of burn is unknown per the reporter.The preparation made for the adherence of device is also unknown per the reporter.The status of the patient is listed as "alive" with no lasting effects other than the 2-irregular round, white marks on the patient's chest, left side greater than the right.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A dhr review could not be conducted as a lot number was not provided.A lot history review could not be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 17 devices, for this device family and failure mode.During this same time frame (b)(4) 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 to select and prepare electrode sites according to your health care facility's protocol for ecg monitoring.And that the electrode site should be dry before electrode application.Fluids, including skin cleansing solutions, lotions or soapy water may cause skin irritation and loss of adhesion.Keep electrode site dry.Additionally, the user is advised that new skin sites should be used with each new electrode application to minimize trauma to the skin.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PROFILE TAPE ELECTRODE, 50
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 10881080
• MDR Text Key: 217661987
• Report Number: 1320894-2020-00511
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K091856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2500-050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR