MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE; 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); Scarring (2061)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt information was not provided.No sample has been received to date.The consumer reported she has no prior history of reactions to medical adhesives or electrodes.
Event or Problem Description
A consumer reported four 2255-50 3m¿ red dot¿ soft cloth monitoring electrodes were applied to her chest for a holter cardiac monitoring test.The consumer alleged she experienced itching and a bright red skin reaction that "looked like a burn" under the adhesive portion of each electrode within 24 hours of application.The electrodes were discontinued and the skin areas were cleansed.The reaction was reported to her md who recommended an unspecified topical ointment.The consumer reported she did not use/apply the topical ointment.The reaction reportedly healed but the consumer alleged she has scarring.

• Brand Name: 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 7362190
• Report Number: 2110898-2018-00033
• Device Sequence Number: 13484988
• Product Code: DRX
• UDI-Device Identifier: 10707387569584
• UDI-Public: 10707387569584
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 2255-50
• Device Lot Number: 2019-09 HB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/22/2018
• 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: Other
• Patient Age: 52 YR