MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDGEL STRESS / DIAPHORETIC FOAM ELECTRODE; ELECTRODE,ECG,STRESS,FOAM,3PK

Catalog Number	MDSM611903
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Tachycardia (2095)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, she had an extreme reaction to electrodes that were used on her.According to the customer, the "areas were red and itchy once electrodes were removed.".
Additional Manufacturer Narrative
According to the customer, she had an extreme reaction to electrodes that were used on her.According to the customer, the "areas were red and itchy once electrodes were removed.She felt unwell, so she had a bath and took reactine, then applied calamine lotion to the areas.Within 1 hour, felt unwell, her blood pressure went 195/? (didn't remember the diastolic pressure).Her pulse was over 120bps.She had to call an ambulance and was in hospital all day.Her b.P was up and down all day and she believed that she was going to die".There was no further information.It has been determined that the reported event caused or contributed to a death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: MEDGEL STRESS / DIAPHORETIC FOAM ELECTRODE
• Common Device Name: ELECTRODE,ECG,STRESS,FOAM,3PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25449298
• Report Number: 1417592-2026-02330
• Device Sequence Number: 9510604
• Product Code: DRX
• UDI-Device Identifier: 80884389830443
• UDI-Public: 80884389830443
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDSM611903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female