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

Model Number 2670-5

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Peeling (1999); Skin Tears (2516); Skin Disorders (4543)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

Anesthesia placed ekg dots on patients face for nerve monitoring.At the end of the case, the crna pulled the ekg adhesives off the patient's left side of her face and it pulled off all the skin.Area was covered with adaptic, 4x8 gauze and paper tape.

• Brand Name: RED DOT
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 12582929
• MDR Text Key: 274946174
• Report Number: 12582929
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2021,09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2670-5
• Device Catalogue Number: 2670-5
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA