MAUDE Adverse Event Report: COVIDIEN ELECTRODE ECL 530 MEDITRACE FM; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31013926

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports: the patient is experiencing a burning sensation from the gel on the electrodes.A patient had a serious reaction to the gel that resulted in scabs forming and slight scaring after healing.Additional information received from the customer stated that the burn was a 2nd - 3rd degree burn approximately 28mm that resulted from the reported incident.

Manufacturer Narrative

Additional information received from the initial reporter confirmed that the product was reported incorrectly.The product device involved in this incident was item #31013926.Section d1 and section d4 were updated accordingly.An investigation including product analysis is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Samples were returned for evaluation consisting of 14 unopened pouches (30 packs) and 1 opened pouch (2 electrodes).The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations or nonconformances initiated with this lot code.The samples returned were confirmed to be product code 31013926 (530 foam electrodes).A visual examination of product samples from the returned unopened pouch indicated no abnormalities.Residual monomer testing was completed according our procedure.The hydrogel from the customer returned samples was subjected to residual monomer testing (3 sample prep - using 12 electrodes for each sample prep) 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 result indicated maximum trace amount of acrylic acid at 647.9, 606.5 & 658.9 ppm which is well within the established product specification of 2000 ppm maximum limit; therefore, the reported condition of skin irritation is not confirmed.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.Since this complaint is unconfirmed and no complaint trend exists, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: ELECTRODE ECL 530 MEDITRACE FM
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 10684782
• MDR Text Key: 211856228
• Report Number: 9681860-2020-00516
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20884527008282
• UDI-Public: 20884527008282
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

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
• Device Operator: No Information
• Device Model Number: 31013926
• Device Catalogue Number: 31013926
• Device Lot Number: 913702X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/07/2020; 10/07/2020
• Supplement Dates FDA Received: 11/19/2020; 12/07/2020
• Patient Sequence Number: 1