MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31013926
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that they have developed a severe allergy to the adhesive electrodes used during treatment.The patient had an extensive rash that started in the middle of their face and descended to their knees.The area was bright red and they had an intense burning sensation accompanied by severe itching, trembling and chills.No product was applied before the electrodes.About 1/2 hour after the placement of the electrodes the skin reaction appeared while the electrodes were still on their skin.The first treatment was oral and it didn't help keep the reaction from progressing.Intravenous corticosteroids were given and the patient was under observation on a heart monitor and blood pressure, lying on a stretcher.The patient had to undergo a second intravenous corticosteroids treatment which worked.
Additional Manufacturer Narrative
A device history record review could not be conducted because a lot number was not provided.Therefore, a review of the specific manufacturing and inspection records was not possible.However, all product lots are required to meet established acceptance criteria and must successfully pass defined visual and functional inspections prior to release.There were no devices or photos returned for evaluation; therefore, the affected device could not be evaluated, and a definitive root cause could not be determined.A corrective and preventive action is not required at this time.We will continue to monitor and take actions, as applicable.

• Brand Name: KENDALL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24679862
• Report Number: 1423537-2026-00080
• Device Sequence Number: 9706363
• Product Code: DRX
• UDI-Device Identifier: 20192253017196
• UDI-Public: 20192253017196
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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
• Device Model Number: 31013926
• Device Catalogue Number: 31013926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female