MAUDE Adverse Event Report: CONMED CORPORATION CLEARTRACE; 5; TP, ADGEL; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 1700-005

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; however, the provided photographic evidence exhibits the reported failure of patient biting into the device.The manufacturing documents from the device history record could not be reviewed because the lot number for the device is unknown.(b)(4).Per the instructions for use, the user is advised the following: intended use: an electrocardiograph electrode is an electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor via lead wires and cables that produce an electrocardiogram to be used by the clinician in diagnosing or monitoring a patient's condition.Product description: these 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that 1700-005 device was bitten by a dementia patient and "a part of the plastic base and gel were swallowed" on (b)(6) 2019.It was reported that the patient was not undergoing a surgical procedure at the time of event; however, a medical staff were in attendance with the patient.It is unknown if the devices had been applied to the patient or if the devices were just in the room at the time of event.An endoscopic examination was performed; however, the device pieces were not located.It is unknown if the patient passed the pieces naturally.The reporter has stated that there was no injury reported and no adverse effects were found with the patient that would require any medical intervention or hospitalization.This report is being raised on the basis of injury due the fragments that were swallowed and are now unknown for location.

• Brand Name: CLEARTRACE; 5; TP, ADGEL
• 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: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 8926843
• MDR Text Key: 155936129
• Report Number: 1320894-2019-00292
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1700-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other