MAUDE Adverse Event Report: CARDINAL HEALTH 200 MEDI-TRACE 100 PK 1000 CA; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31050522
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Asthma (1726)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer report an allergic reaction to ecg electrodes that caused an anaphylactic reaction, asthma attack and hives after a sleep study.
Additional Manufacturer Narrative
A review of the device history record was not completed as the lot number was unknown.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, therefore a date of manufacture could not be determined.A sample was not received with this complaint therefore, it is not possible to confirm the reported condition.From a root cause analysis perspective, the cause of the skin irritation it is most likely attributed to skin preparation, skin condition or specific skin sensitivities.It can also be caused by repeated placement of the electrodes in the same position which can irritate the skin.Biocompatibility testing is performed in accordance with iso 10993-1 and gel was found to be non-cytotoxic, non-irritating and non-sensitizing.The results of the manufacturing facility investigation were unable to confirm an exact root cause associated with the manufacture of product which would have contributed to the reported condition.Since this complaint is unconfirmed, no complaint trend exists and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 200 MEDI-TRACE 100 PK 1000 CA
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12741189
• Report Number: 9681860-2021-00524
• Device Sequence Number: 4099827
• Product Code: DRX
• UDI-Device Identifier: 20884527007926
• UDI-Public: 20884527007926
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/04/2022

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: 31050522
• Device Catalogue Number: 31050522
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/04/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown