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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, weight, ethnicity, race: not available.Lot number and expiration date are not available.Manufacture date not available.Device has been discarded.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 determine the root cause of the alleged injury or whether a patient plate was the root cause.This is an on-going low-level issue which was identified through customer complaints.Multiple studies are regularly conducted that have demonstrated appropriate device biocompatibility and safety performance criteria when the device is used appropriately on humans.The red dot electrodes have been subject to a 3m board certified toxicologist review and have been subject to biological testing to confirm they are safe for their acceptable use.In addition to performing clinical studies, 3m monitors its medical devices with manufacturing controls such as: residual solvent release specifications and testing.Adhesive basis weight controls.Retain samples.Function release specifications and testing.Despite these studies and controls, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products.The patients may also have delicate skin type or sensitivity to skin prep materials.To monitor these situations, medical complaints are trended to allow for appropriate corrective action to be taken if the trend deviates from historical values.Medical complaints represent a wide range of impacts on the patient from mild sensitivity to serious medical conditions.The impact on individual patients is an individual situation involving a wide range of factors (patient health, skin prep, patient allergies, application techniques, removal techniques, ect.Known failure modes include allergies and sensitivities to adhesives or other components and incorrect use of product.
Event or Problem Description
A (b)(6) year-old female customer reported anaphylactoid symptoms after use of 3m¿ red dot¿ monitoring electrode, 2268-3 for a ct scan.Patient has an extensive allergy list; she carries an albuterol inhaler and epi pen routinely.She has had these symptoms from prior exposure to many chemicals.Four electrodes were applied and within five minutes she experienced a burning sensation under the electrode.The electrodes were removed, and the skin was cleansed.Patient alleged she started feeling asthmatic symptoms, coughing, heavy chest, vision changes of the room becoming dark and a "deep cloud" feeling.The nursing staff brought her over to urgent care; she had already been using her albuterol inhaler; symptoms would subside for approximately ten minutes with use of the inhaler.While waiting to be seen patient self-administered her epi pen.Less than fifteen minutes later the symptoms resolved.She discharged herself and was not seen by a clinician.

• Brand Name: 3M RED DOT MONITORING ELECTRODES
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 12037840
• Report Number: 2110898-2021-00039
• Device Sequence Number: 4421520
• Product Code: DRX
• UDI-Device Identifier: 10707387789531
• UDI-Public: 10707387789531
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 2268-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/21/2021
• 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: 62 YR