MAUDE Adverse Event Report: COVIDIEN ELECTRODE H49P SOLID GEL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	ES40030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Irritation (2076)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the patient experienced fluid discharged blisters, raised yellowish color bumps, irritation and itchiness after the use of three electrodes.The patient did not report having skin sensitivities or allergies.The instructions for use were not followed, the patient did not replace the old electrodes with new ones, instead they reused the electrodes.The patient did not consult a clinician, self treat, or self medicate.

• Brand Name: ELECTRODE H49P SOLID GEL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 10596939
• Report Number: 1219103-2020-00303
• Device Sequence Number: 19750285
• Product Code: DRX
• UDI-Device Identifier: 20884527004796
• UDI-Public: 20884527004796
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: ES40030
• Device Catalogue Number: ES40030
• Device Lot Number: 000759X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR