MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ SOFT CLOTH 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	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The consumer did not have product catalog or lot numbers.3m contacted the distributor who provided the product information.No samples or photos have been received for this report.The consumer would not provide consent to contact her health care provider for information related to this report.A review of the quality documentation related to the electrode product lot did not reveal any quality issues with the product.
Event or Problem Description
A consumer reported 3m red dot electrodes and a bodyguardian® verite heart monitor were being used for a 30-day cardiac monitoring test.The consumer reportedly wore the electrodes for 13 days without issue.On the 14 day, she reportedly started to experience a "tingling sensation" under the electrode stubs and the following day, the "tingling sensation" became intense.The consumer reported the monitor and lead wires were heating up.The consumer stated she was seen in an urgent care and diagnosed with "2nd degree electrical burns on four chest sites due to a faulty electrode monitor." she was reportedly given a prescription for silvadene cream and received a tetanus (tdap) shot.She was instructed to follow-up the same day at a walk-in clinic to evaluate the skin burns and was seen by a dermatologist.She was given an rx for santyl ointment, instructed to take ibuprofen.She was also instructed to follow-up with her cardiologist.

• Brand Name: 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODES
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8612001
• Report Number: 2110898-2019-00073
• Device Sequence Number: 2523025
• Product Code: DRX
• UDI-Device Identifier: 10707387507845
• UDI-Public: 10707387507845
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: Lay User/Patient
• Device Expiration Date: 12/15/2020
• Device Model Number: N/A
• Device Catalogue Number: 2660-5
• Device Lot Number: 2020 -12 EW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/15/2019
• 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: BODYGUARDIAN VERITE HEART MONITOR SERIAL (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention