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

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Consumer reported the event occurred in (b)(6) 2018.Specific date was not provided.(b)(6) 2018 was used for date of event in this report.Lot number was not provided.Without a lot number, expiration date and manufacture date could not be determined.Full reporter information (email and phone number) was not provided.The consumer reported the event occurred in (b)(6) 2018.There was neither a product sample available for analysis nor a lot number provided for evaluation of any specific manufacturing or release documentation.Although the consumer reported 2560 3m¿ red dot¿ electrodes were applied, the report also indicated more than one type of electrode (possibly from a different manufacturer) may have been applied to this consumer.No information was available regarding other electrodes applied to the consumer.Based on the information provided, the reported reaction may be an individual sensitivity / allergic contact dermatitis.End of report.
Event or Problem Description
A consumer reportedly experienced an allergic reaction described as itching, redness, swelling, blisters, folliculitis and skin tears following use of 2560 3m¿ red dot¿ foam monitoring electrodes.The consumer also reported experiencing general malaise, fatigue and headaches.Dermatology and allergy specialists were consulted.The reaction was treated with and unspecified type of allergy medication and cortisone cream.The consumer reported the skin was no longer open and minimal scaring occurred.

• Brand Name: 3M¿ RED DOT¿ FOAM MONITORING ELECTRODES
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8316340
• Report Number: 2110898-2019-00024
• Device Sequence Number: 13469239
• Product Code: DRX
• UDI-Device Identifier: 10707387463257
• UDI-Public: 10707387463257
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 2560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/07/2019
• 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: 42 YR