MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH 3M¿ MICROPORE¿ TAPE BACKING; ECG ELECTRODE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Limited reporter information was provided.
Event or Problem Description
A distributor reported that a nurse alleged that a patient experienced itchiness of the skin during monitoring with twelve 2239 3m¿ red dot¿ electrodes with 3m¿ micropore¿ tape backing applied on the chest for 24 hours of holter monitoring in a cerebrovascular center.Redness of the skin was alleged when the electrodes were removed the next day.The electrodes were not reapplied after the skin symptoms occurred.Pheniramine was prescribed the morning after electrode removal.A dermatologist examined the patient and prescribed l-triazine (5mg, #1, orally) and elocom cream, 15g for contact dermatitis.

• Brand Name: 3M¿ RED DOT¿ MONITORING ELECTRODE WITH 3M¿ MICROPORE¿ TAPE BACKING
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8724368
• Report Number: 2110898-2019-00083
• Device Sequence Number: 2022573
• Product Code: DRX
• UDI-Device Identifier: 10707387104426
• UDI-Public: 10707387104426
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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 Expiration Date: 01/22/2020
• Device Model Number: N/A
• Device Catalogue Number: 2239
• Device Lot Number: 2020-01 ZN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR