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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/09/2019

Event Type  Injury  

Event Description

A consumer reported approximately eight 2360 3m¿ red dot¿ ekg resting electrodes were applied to her legs, arms, collar bone and under her breast for less than 5 minutes during an ekg test.Later the same day, the consumer reportedly experienced red raised bumps, itching and welts where each electrode had been applied.The following day, itching, hives, redness and a rash spread outward from each electrode site.The consumer was seen by her primary physician and was treated with a steroid injection.The consumer reported the reaction was improving.

• Brand Name: 3M¿ RED DOT¿ RESTING EKG ELECTRODES
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTHCARE/3M VALLEY; 600 east meigs st.; valley NE
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8555879
• MDR Text Key: 143385751
• Report Number: 2110898-2019-00068
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00707387472825
• UDI-Public: 00707387472825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 49 YR