MAUDE Adverse Event Report: 3M RED DOT REPOSITIONABLE MONITORING ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 2670-5

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 05/04/2017

Event Type  Injury  

Event Description

Serious skin reaction after using 3m red dot monitoring electrodes.

• Brand Name: RED DOT REPOSITIONABLE MONITORING ELECTRODES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M
• MDR Report Key: 6559875
• MDR Text Key: 75002764
• Report Number: MW5069688
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00707387499969
• UDI-Public: (01)00707387499969
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/09/2017

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 Operator: Health Professional
• Device Model Number: 2670-5
• Device Lot Number: 2017-03 EG
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADEMPAS; AZOR; BACLOFEN; CELEXA; CYTOMEL; OTC MEDS: NA; OXYGEN; RX MEDS: LETAIRIS; SYNTHROID; WELLBUTRIN
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 115