MAUDE Adverse Event Report: COVIDIEN KENDALL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31013926

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

Patient Problem Unspecified Infection (1930)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were no samples submitted with this complaint; however, the complaint will be reopened if a sample is later received.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis.Had a sample been received, it would have been evaluated against the established product requirements.Due to the nature of this type of product, it is more than likely that any skin irritation is related to skin sensitivity, and it is worth noting that patient sensitivities may have been a contributing factor.Previous complaints of this nature have not been known to cause permanent impairment or marking.This product family has been tested according to iso 10993 guidelines for biocompatibility that 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.As this complaint is unconfirmed and no complaint trend exists, a corrective action is not deemed necessary at this time.This complaint will be recorded for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that a patient had a skin issue as a result of holter monitoring and was given an antibiotic cream to treat an infection.It is unknown how long the electrodes were in place for this patient.The customer further reported that usual skin prep of an alcohol cleanse, 3m abrader tape and 5300 foam electrodes were used for monitoring.

• Brand Name: KENDALL
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque,on K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque,on K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7175911
• MDR Text Key: 96764573
• Report Number: 9681860-2018-00001
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31013926
• Device Catalogue Number: 31013926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other