MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ECG FOAM ELECTRODE

Catalog Number MDSM611950

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Skin Irritation (2076); Swelling (2091)

Event Date 12/23/2014

Event Type  Injury  

Event Description

The end user developed an allergic reaction after wearing the electrodes.

Manufacturer Narrative

It was reported that the end user had the electrodes applied to place a halter monitor due to the palpitations.Several hours after wearing the electrodes she reported that she developed some skin irritation and her lips started to swell.She was treated with steroids from which she had good results.She was told she may have experienced an allergic reaction to the adhesive on the electrode.The actual sample was discarded.Unused samples were returned for evaluation.The visual inspection did not reveal any abnormalities or defects.There were no functional defects identified.It is not known if the end user had known sensitivities to adhesive materials or if there were any underlying factors that may have played a role in this incident.However, due to the need for medical intervention and in an abundance of caution, this medwatch is being field.

• Brand Name: ECG FOAM ELECTRODE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4733846
• MDR Text Key: 18892333
• Report Number: 1417592-2015-00028
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDSM611950
• Device Lot Number: 15114S08GF50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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
• Patient Age: 28 YR