MAUDE Adverse Event Report: COVIDIEN ELECTRODE ADULT MONITOR FOAM; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31115788

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

Patient Problem Necrosis (1971)

Event Date 09/09/2020

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 electrode caused necrosis on a burn patient.The patient had electrodes on from (b)(6) 2020 until (b)(6) 2020, with the electrodes being changed every three days.The electrodes were placed directly on the patient's skin.The cardiac monitor was immediately evaluated by biomed for proper function.A skin biopsy was done and the wounds were left in the air for drying.There was no medication prescribed.Surgical debridement is being performed as needed.The patient is currently doing very well.

Manufacturer Narrative

Necrosis is a condition when skin tissue dies and becomes dehydrated.The lot code submitted is confirmed.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 condition 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 samples submitted with this complaint; however, there was one photo submitted with the complaint.Because no sample was returned with this complaint, a product examination was not possible.Although it is evident that the patient experienced necrosis under the electrode pad the investigation could not confirm anything manufacturing related that could have contributed to this outcome.Therefore, this complaint is unconfirmed as a product issue.It is worth noting the precautions on the directions for use does not recommend putting electrodes on broken skin with cuts or lesions, scar tissue or infections.Because the patient was burned severely this may have contributed to the necrosis experienced by the patient.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.The foam adhesive is an acrylic based pressure sensitive adhesive.The raw material certifications for the release liner & web foam material was reviewed; material met product specifications and no issues or abnormalities were identified that may have contributed to the issue of necrosis.The adhesive gel formulation is proprietary but consists of 20-35% water, 32-47% glycerin, 25-35% polyacrylate copolymer, 0.5-4.5% salt (potassium chloride), and 0.1-0.6% catalyst system are the base properties to assist in determining whether there is any skin sensitivity or allergies.The hydrogel formulation was reviewed and verified the gel was made accordingly and met the specification requirements.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 ADULT MONITOR FOAM
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 10596949
• MDR Text Key: 208859534
• Report Number: 9681860-2020-00515
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20884527008039
• UDI-Public: 20884527008039
• 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
• Report Date: 11/18/2020

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: 31115788
• Device Catalogue Number: 31115788
• Device Lot Number: 012702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other