MAUDE Adverse Event Report: 230 MEDI-TRACE 30 PK 600 CA; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31078135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Scar Tissue (2060); Blister (4537)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.The results will be shared when available.
Event or Problem Description
The reporter stated that she had an allergic reaction to the electrode patches and has burn like injuries on her body.Additional information provided stated that her throat started to close making this a life threatening situation.The reaction was located on her chest and under her left breast.She reacted to all five electrodes used.She consulted her allergist because she felt short of breath.She was prescribed 50mg of benadryl which she took every eight hours for two days and one dose of 20mg of prednisone.She also self-treated by washing the areas with soap and water to remove the gel and patted the areas dry.The areas were blistering so she left them open in the air until scabs formed.She now has scars in the affected areas.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and indicated that no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process, no deviations or non-conformances were documented.One sample was received for the investigation.The sample arrived in an opened pouch.It was visually inspected and there were no abnormalities identified.The electrode was then subjected to residual monomer testing to ensure that the gel is properly cured.The result for the testing performed on the single electrode was well below the maximum limit.This product family has been tested according to iso 10993 guidelines for biocompatibility and found both the hydrogel and skin contacting foam adhesive to be non-cytotoxic, non-irritating, and non-sensitizing.There have been no design changes to this product within the past year that would contribute to any increased probability for skin irritation on patients.Based on all available information, a corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures and no trends have been identified.The details of this event will be recorded for tracking and trending purposes.

• Brand Name: 230 MEDI-TRACE 30 PK 600 CA
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• MDR Report Key: 12594397
• Report Number: 9681860-2021-00521
• Device Sequence Number: 17216017
• Product Code: DRX
• UDI-Device Identifier: 20884527007933
• UDI-Public: 20884527007933
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: No Information
• Device Model Number: 31078135
• Device Catalogue Number: 31078135
• Device Lot Number: 001369X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention