MAUDE Adverse Event Report: CARDINAL HEALTH 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31.1925.21

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

Patient Problems Urticaria (2278); Discomfort (2330)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that a patient had an allergic reaction after performing an electrocardiogram with the electrode.He reported urticaria, rashes that spread from the areas where the electrodes were placed to the arms, legs, abdomen, back and face.He had discomfort in the throat which made him go to the emergency room for treatment.Per additional information received, the trip to the emergency room was for the allergic reaction.Dexchlorpheniramine and methylprednisolone was given as medical intervention.The patient is doing fine now.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality requirements.The product was manufactured in october of 2021.One sealed pouch was returned for the investigation.The samples were evaluated against the inspection procedure for release control, and it was determined that all requirements were fulfilled, all parts were existing, and there was no damage to the product.Wearing tests were completed on human skin and none of the volunteers developed a skin irritation or allergic reaction.The most probable root cause is that the described allergic reaction was caused by an intolerance against one or more components of the electrode, pre-treated skin, or medication of the patient that leads to allergic reactions.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• Manufacturer (Section G): CARDINAL HEALTH; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13893038
• MDR Text Key: 287849990
• Report Number: 9710060-2022-00210
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/25/2023
• Device Model Number: 31.1925.21
• Device Catalogue Number: 31.1925.21
• Device Lot Number: 21300C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other