MAUDE Adverse Event Report: INTCO MEDICAL CO. ELECTRODE, ECG, MONITORING, SS SNAP, FOA; ELECTRODE, ELECTROCARDIOGRAPH

Model Number E510FATM

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Radiation Burn (1755)

Event Date 09/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record could not be verified as a lot number was not provided.No samples were received for evaluation so therefore the supplier is unable to determine a root cause for the issue reported.A review of historical complaint records from 2004 through 2015 showed no incidence of burns reported.Review of the material record showed that the materials are in compliance for biocompatibility.The reported incident could not be repeated or confirmed in this investigation.We will continue to monitor for any similar reports.

Event Description

The customer, (b)(6) state patrol officer, allegedly sustained burns on her chest and abdomen during a ecg procedure that was performed at (b)(6).She reports that she does not believe that the lead or electrodes are to blame for the burn, but believes it was caused due to being prepped incorrectly.

• Brand Name: ELECTRODE, ECG, MONITORING, SS SNAP, FOA
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): INTCO MEDICAL CO.; unit 04 7 f bright way tower; hong kong ; CH
• Manufacturer (Section G): INTCO MEDICAL COMPANY; unit 04 7 f bright way tower; hong kong ; CH
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5294959
• MDR Text Key: 33443346
• Report Number: 1423537-2015-00075
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015,12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E510FATM
• Device Catalogue Number: E510FATM
• Device Lot Number: NO LOT GIVEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2015
• Event Location: Clinic - Walk In; Other
• Date Report to Manufacturer: 11/19/2015
• Date Manufacturer Received: 11/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other