MAUDE Adverse Event Report: CONMED CORPORATION CLEARTRACE 10 ELECTRODE; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 1700-010

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

The "used/damaged" 1700-010 cleartrace electrode was not returned to conmed and no visual evidence (photographs) were provided for the complaint of "skin irritation." a failure analysis could not be completed for this reported failure, therefore this complaint is unconfirmed.The 1700-010 cleartrace electrodes are made with 2000x gel and the base pad with vinyl.Both materials are tested for cytotoxicity, sensitization, and intracutaneous factor per iso approved testing.There are several non-manufacturing, non-design factors that could be contributing to this complaint issue.The 1700-010 cleartrace ecg electrodes are single use, disposable devices that are intended to be used by experienced and trained medical personnel in hospitals, clinics, physician offices and pre-hospital environments.The complaint device was supplied to the patient for home use without monitoring by experienced personnel.It is possible that the patient had solvents or other fluids under the electrode site such as soap, detergent, lotions or creams which may have caused or contributed to the irritation.It is also possible the patient has sensitivity to the materials found in ecg electrodes.The manufacturing, date, lot size and review of the manufacturing documents were not obtainable as the lot number of the device involved in this complaint has not been provided.This failure mode is addressed in the risk documents.A health hazard evaluation (hhe) was conducted and found that most reports of skin sensitivity, allergy, lesions, blisters and irritation caused by the use of medical adhesive/conductive gel products are usually treated conservatively and do not result in serious injury.These reactions and irritations are a non-serious injury that normally resolve upon cessation of product use and require no further treatment.To date there have been no long term adverse effects reported for skin reactions requiring medical intervention however, a corrective and preventative action has been issued to reduce skin irritation recurrences for "in home use" of these devices.Discarded by consumer.

Event Description

As reported, the patient developed a skin irritation after three (3) weeks of using the 1700-010 cleartrace electrodes.This irritation was characterized as "itchiness, redness, sores, bumps and chills" the physician diagnosed an infection and prescribed a cortisone injection and triamcinolone 0.1% topical cream.Follow up on (b)(6) 2017 revealed that the patient still has rings around the electrode area.

• Brand Name: CLEARTRACE 10 ELECTRODE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• 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: kimber boss ; 525 french road; utica, NY 13502-5994 ; 3156243441
• MDR Report Key: 6549164
• MDR Text Key: 74555753
• Report Number: 1320894-2017-00100
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1700-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR