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

Model Number	31043170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Discomfort (2330); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	12/08/2024
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 an adverse reaction after using the kendall 7605 cloth electrodes with conductive adhesive hydrogel, ref 31043170.On december 4, 2024, they used these electrodes as part of a holter monitor test that was intended to last for 14 days.Unfortunately, the patient had to remove the electrodes after just 4 days due to a severe allergic reaction.The reaction caused significant blistering, scabbing, pain, itching, and general discomfort.Since removing the electrodes, they have continued to experience redness, bumps, itching, and irritation, along with scarring in the affected areas.Their skin remains sore and tender, and the irritation has not fully subsided.Photos attached.Additional information received on 09 jan 2025 stated that the customer consulted with her pharmacist regarding the skin irritation.After assessing the condition, the pharmacist recommended the use of polysporin triple antibiotic ointment due to the presence of open sores and the risk of infection, as the area appeared inflamed and was painful.Additionally, the pharmacist advised a trial of local corticosteroids after a few days to help manage inflammation.She was also prescribed antihistamines (blexten) for symptomatic relief.A consultation with her physician was also taken for further evaluation and management.She continued to take antihistamines for symptomatic relief, but the affected area remains irritated, itchy, and erythematous, with persistent raised bumps.Despite treatment, there has been no significant improvement in the condition.
Additional Manufacturer Narrative
The device history record (dhr) for lot 408217x was reviewed and no anomalies related to the reported issue were observed.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.Three photos were provided and evaluated.The photos show large circular red marks on the patient¿s chest area.The marks appear to be where the adhesive was in contact with the patient¿s skin.Two physical samples were also provided for evaluation.The samples appear to be unused.The samples are intact and no issues or defects were observed.Based on all available information, no device problem was found and a definitive root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• 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; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21256911
• Report Number: 1423537-2025-00052
• Device Sequence Number: 8205944
• Product Code: DRX
• UDI-Device Identifier: 20192253017226
• UDI-Public: (01)20192253017226(17)270307)(10)408217X
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 31043170
• Device Catalogue Number: 31043170
• Device Lot Number: 408217X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female