MAUDE Adverse Event Report: 3M RED DOT; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 2235

Device Problem Use of Device Problem (1670)

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

Patient felt a burning sensation during mri test.Patient believed to have sustained thermal wound during mri exam of the lumbar spine.Patient with fragile skin and when telemetry electrode sticker was removed injury observed to skin.We believe the electrode was likely left on the skin during the mri exam.

• Brand Name: RED DOT
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M; 3m center, 2510 conway ave; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 7451233
• MDR Text Key: 106211918
• Report Number: 7451233
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2235
• Device Catalogue Number: 2235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, ELECTRODE; YES, TELEMETRY ELECTRODE
• Patient Outcome(s): Other
• Patient Age: 91 YR