MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ MONITORING ELECTRODES; ECG ELECTRODE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number was not provided.Without a lot number, expiration date and manufacture date cannot be determined.
Event or Problem Description
A hospital imaging manager alleged three 2670-5 3m¿ red dot¿ soft cloth monitoring electrodes were applied to a patient in the emergency room.A few hours following application of the electrodes, the patient was transferred to the imaging area for an mri procedure.The patient did not have cardiac monitoring during the mri, but the electrodes were reportedly left on his skin.The patient stated he felt pain under the electrodes during the mri but did not say anything until the test was completed.The patient allegedly experienced circular burns under the electrode stubs.He was seen by a physician in the er and was treated with rx silvadene cream.

• Brand Name: 3M¿ RED DOT¿ MONITORING ELECTRODES
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8297707
• Report Number: 2110898-2019-00019
• Device Sequence Number: 13941390
• Product Code: DRX
• UDI-Device Identifier: 10707387499966
• UDI-Public: 10707387499966
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2670-5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MRI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR