MAUDE Adverse Event Report: 3M CANADA COMPANY 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE; ELECTROCARDIOGRAPHIC ELECTRODE

Catalog Number 2238

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Skin Discoloration (2074)

Event Date 06/28/2023

Event Type  Injury  

Event Description

A patient allegedly experienced localized skin flushing and an itching sensation one day post application of the 3m¿ red dot¿ soft cloth monitoring electrode, 2238 lot 20220607.The electrodes were removed, prescribed topical fluocinolone ointment was applied, and the symptoms resolved the following day.

Manufacturer Narrative

-a1-a6: patient specifics: not provided -d4: lot number and expiration date: not available -h4: manufacture date: not available -h10: product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.The instructions for use states, 3m¿ red dot¿ soft cloth monitoring electrode, 2238 are disposable, intended for single use, and has been tested for up to 3 days wear.To minimize skin irritation: · avoid placing an electrode on an irritated skin site.· do not abrade a skin site more than one time.· avoid removing electrodes frequently and/or reapplying to the same skin site.· avoid placing electrodes on skin still wet from an alcohol wipe (dry thoroughly).· assess electrode sites periodically.

• Brand Name: 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE
• Type of Device: ELECTROCARDIOGRAPHIC ELECTRODE
• Manufacturer (Section D): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17430926
• MDR Text Key: 320115813
• Report Number: 2110898-2023-00071
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387788848
• UDI-Public: 10707387788848
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• 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