MAUDE Adverse Event Report: CONMED UTICA INVISITRACE ADULT MONITORING ELECTRODE (600/CS); ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 1680-030

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 02/10/2022

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, 1680-030, invisitrace adult monitoring electrode, was being used by the patient on (b)(6) 2022 when it was reported ¿patient has sensitive skin and eczema and had symptoms after 1680-030 invisitrace.Rash and electrode skin irritation.Entire electrode area affected.¿.The reporter states that the patient consulted a healthcare professional due to rash/skin irritation and triamcinolone acetone cream 0.1% was prescribed.No hospitalization was reported for the patient.This report is being raised on the basis of injury due to medical intervention requiring prescription medication from healthcare professional.

Event Description

The customer reported that the device, 1680-030, invisitrace adult monitoring electrode, was being used by the patient on (b)(6) 2022 when it was reported ¿patient has sensitive skin and eczema and had symptoms after 1680-030 invisitrace.Rash and electrode skin irritation.Entire electrode area affected.¿.The reporter states that the patient consulted a healthcare professional due to rash/skin irritation and triamcinolone acetone cream (b)(4) was prescribed.No hospitalization was reported for the patient.This report is being raised on the basis of injury due to medical intervention requiring prescription medication from healthcare professional.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event 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.There are two complaints for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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 cleansing solutions, lotions or soapy water may cause skin irritation and loss of adhesion.Keep electrode site dry.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: INVISITRACE ADULT MONITORING ELECTRODE (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: 13768970
• MDR Text Key: 291636283
• Report Number: 1320894-2022-00057
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/04/2023
• Device Catalogue Number: 1680-030
• Device Lot Number: 202110041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic