MAUDE Adverse Event Report: CONMED CORPORATION EXACTRACE; 1; FM, WTGEL; ELECTROCARDIOGRAPH ELECTRODE

Catalog Number 1510-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/24/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is unable to be confirmed due to the device being discarded by the hospital.These electrodes contain lectron iii 4% gel component and a pe foam component which has been tested for cytotoxicity, sensitization and intracutaneous.A review of device history revealed 4 complaints have been reported in the past two years.During this same two-year time frame, (b)(4) devices have been sold worldwide making the calculated occurrence probability (b)(4).A risk analysis was performed and determined the risk to be acceptable.The ifu states the following to mitigate this potential issue: "select and prepare electrode sites according to your health care facility's protocol for ecg monitoring.The electrode sites should be clean, dry, and free from skin oil prior to electrode application.Check the expiration date on the un-opened pouch of electrodes.Electrodes must be used before expiration date indicated on the package.To minimize skin trauma during electrode removal, lift slowly and gently from the peel tab or electrode edge." to date, there have been no patient long term effects resulting from this reported problem.The reported problem will continue to be monitored through the complaint system to ensure patient/product safety.Device was discarded by user facility.

Event Description

Conmed corporation received a product experience report containing adverse event information from the (b)(6).Symmetrical to the exactrace electrode placement, there was a large red bubbling area on the skin of the thigh.This was primarily interpreted as an allergic reaction.This developed over time and the wound started to develop an infection.The wound became deep and the patient has problems in the form of pain, etc.And still has today.At this time, we have been unable obtain additional patient/event information.

• Brand Name: EXACTRACE; 1; FM, WTGEL
• Type of Device: ELECTROCARDIOGRAPH ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502-5994 ; 7273995209
• MDR Report Key: 6658562
• MDR Text Key: 78126131
• Report Number: 1320894-2017-00135
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K963787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2017

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
• Device Operator: No Information
• Device Catalogue Number: 1510-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1