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

Model Number N/A

Device Problem Missing Value Reason (3192)

Patient Problems Rash (2033); Scar Tissue (2060); Tissue Damage (2104)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

It was a layman who reported this event and they provided very limited information.The layman did not return the product for evaluation but was noted to have sensitive skin.Device not returned for evaluation.

Event Description

A female customer had four 3m¿ red dot¿ electrodes applied to her chest starting on approximately (b)(6) 2017 for 30 day monitoring.She removed the electrodes three days later and alleged skin redness and itching, mainly under the gel portion of the electrodes.She rotated application sites.She applied over-the-counter topical neosporin (bacitracin, neomycin, polymyxin).She alleged the areas started to ooze with pus.She contacted her doctor and was given an unspecified topical antibiotic.The woman alleged the areas scabbed.On (b)(6) 2017 the customer alleged that she saw the doctor that day.The doctor prescribed an unspecified topical steroid ointment.The customer alleged the skin irritation is under all of the electrodes (i.E., adhesive and gel portions) and that the areas are infected.No oral antibiotic was prescribed.On (b)(6) 2017, the customer alleged dark circles "scars" where the electrodes had been placed.The doctor confirmed on (b)(6) 2017 that the customer has "some sensitive skin" and some unspecified "trouble with her skin." the doctor will evaluate the customer's skin at a future appointment date within (b)(6) 2017.

• Brand Name: 3M¿ RED DOT¿
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 6450351
• MDR Text Key: 71462150
• Report Number: 2110898-2017-00045
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 2255
• Device Lot Number: 2018-11 XE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other