MAUDE Adverse Event Report: 3M/ 3M COMPANY 3M RED DOT SQUARE EKG STICKIES; ELECTRODE, ELECTROCARDIOGRAPH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Date 02/03/2021

Event Type  Injury  

Event Description

I was instructed to use 3m red dots for a holter monitor for 48 hours.I told the doctor and nurse that i had a scar from the last time i wore a 2 week holter monitor, but they didn't seem to think it was due to this.I now have a rash and severe itching and redness where the red dots were stuck to me.Fda safety report id # (b)(4).

• Brand Name: 3M RED DOT SQUARE EKG STICKIES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M/ 3M COMPANY
• MDR Report Key: 11307222
• MDR Text Key: 231583980
• Report Number: MW5099310
• Device Sequence Number: 1
• Product Code: DRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR