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

Model Number ES40030

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

Patient Problems Unspecified Infection (1930); Skin Irritation (2076)

Event Date 08/13/2020

Event Type  Injury  

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 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
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10596939
• MDR Text Key: 208985106
• Report Number: 1219103-2020-00303
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20884527004796
• UDI-Public: 20884527004796
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ES40030
• Device Catalogue Number: ES40030
• Device Lot Number: 000759X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR