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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Limited reporter information was provided.

Event 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
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8724368
• MDR Text Key: 148914751
• Report Number: 2110898-2019-00083
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387104426
• UDI-Public: 10707387104426
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR