MAUDE Adverse Event Report: COVIDIEN ECG STRESS EL MEDITRACE 530 X600; ECG ELECTRODE

Model Number 31013926

Device Problem Gel Leak (1267)

Patient Problems Burn(s) (1757); Scarring (2061); Skin Irritation (2076); Superficial (First Degree) Burn (2685)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

Submit date: 2/18/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an ecg electrode.The customer reports that it was observed that the gel in the electrode was a yellowish color.This caused skin irritation on a patient's skin.Skin was burned and left with scarring.Patient sought medical attention at their family md, no additional information about the specific treatment is available.The customer states that the burns are assumed to be 1st degree.

Manufacturer Narrative

The lot number for this complaint was provided.The device history record review showed that the product had met all defined acceptance criteria inspections during the production process.The product and lot number on the pouch matched the product and lot number reported in the complaint.The actual samples with the reported condition were not received but the samples received are from the same lot number of the electrodes with the reported condition.The returned product consisted of 1 opened pouch containing unused electrodes.The pouch and electrodes were contained within a polybag but the electrodes were not contained within the pouch.A visual examination of the electrodes indicated that all of the electrodes had slight hydrogel discoloration (yellowing); however, the degree of the hydrogel discoloring is not considered a deficiency as there is no impact on product performance.To confirm product performance, a random sample of the electrodes was electrical properties tested according to procedure.The electrical properties test results met product requirements with typical results.A possible cause of hydrogel discoloration (yellowing) is natural product aging that occurs over the life of the product.In addition, extended exposure to high temperatures during storage or transportation may cause acceleration of the natural aging process resulting in discolored hydrogel.Hydrogel yellowing as seen in the returned samples does not impact electrode function and is not considered a product deficiency; therefore, this reported condition is not confirmed.Since the reported condition of hydrogel discoloration (yellowing) is unconfirmed and no complaint trend exists and the most probable cause of the hydrogel discoloration is natural aging, no corrective action is required at this time for this reported condition.Hydrogel from a sample of customer returned samples was subjected to residual monomer testing to determine if high residual amounts of acrylic acid in the hydrogel could have been a contributor to the complaint of skin irritation.The test results indicated maximum trace amounts of acrylic acid at 815.6 ppm which is well within the established product specification of 2500 ppm maximum limit; therefore, the reported condition of skin irritation is not confirmed.

Event Description

The customer photograph provided with this complaint displays a red mark on the patient skin indicating possible minor skin irritation; however, due to the nature of this type of product, it is more than likely that the incident 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 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.Since the reported condition of skin irritation is unconfirmed and no complaint trend exists and the most probable cause of the skin irritation is patient skin sensitivity, no corrective action is required at this time for this reported condition.This complaint will be recorded for tracking and trending purposes.

• Brand Name: ECG STRESS EL MEDITRACE 530 X600
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque ; CA
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5445988
• MDR Text Key: 38520628
• Report Number: 9681860-2016-00002
• 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,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• 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
• Device Lot Number: 514616X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability