MAUDE Adverse Event Report: 3M COMPANY RED DOT¿; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	2670-5
Health Effect - Clinical Codes	Sore Throat (2396); Foreign Body In Patient (2687)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient presented for a porta cath placement (airway type used: laryngeal mask #5).Several hours post discharge, patient experienced excruciating throat pain & sought immediate medical advice followed by medical attention on multiple occasions.Patient arrived at an outside facility, ed to or for direct laryngoscopy w/ [with] removal of retained laryngeal foreign body where a translucent sheet of unknown material, 4.0 x 3.5 cm by less than 0.1 cm, correlating w/ backing of electrode used in procedural areas was removed just above true vocal folds, lodged against arytenoids.Patient reported immediate improvement in symptoms and discharged in stable condition.A translucent foreign object entered the intubation/surgical field and went unnoticed by the surgical team because it was difficult to visually detect.This occurred in part because the manufacturers did not evaluate visibility risks of clear materials with no marking.

• Brand Name: RED DOT¿
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 12930 ih 10 west; san antonio TX 78249
• MDR Report Key: 24839153
• Report Number: 24839153
• Device Sequence Number: 9686802
• Product Code: DRX
• UDI-Device Identifier: 50707387499964
• UDI-Public: (01)50707387499964
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/31/2026
• Report Date (Section F): 04/01/2026

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 Model Number: 2670-5
• Device Catalogue Number: 2670-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/01/2026