MAUDE Adverse Event Report: COVIDIEN ALL PURPOSE FOAM ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	87-50SG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported that the adhesive has twice pulled (thin) skin off of elderly patient.The patient had skin tear.The patient was instructed to use vaseline gauze and followed up with her dermatologist.
Additional Manufacturer Narrative
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 samples returned for the evaluation.Therefore, no product examination was possible, and the reported condition could not be confirmed as a manufacturing issue.A picture has been provided for the analysis.Upon picture evaluation, a layer of skin approximately 1/3 the size of the electrode attached to the adhesive indicating that the flap was completely removed with the tear.The complaint did mention an elderly patient, which could put the patient at higher risk with complications of skin tear.Based on the information provided in the complaint record, there are a few potential causes of skin tear, which includes: ¿ skin tear can be caused by force trauma during removal.If the area under the electrode is red and raised and the skin has ¿torn¿ causing bleeding it could be that the removal force was too fast/strong.Holding the skin at the edge of the electrode and slowly pulling the electrode from the skin will alleviate this type of tears.¿ the adhesive is too aggressive for the patient and application.Placing the electrode on the exact same site can also cause tear.The electrodes should be moved around to new sites to prevent skin tears.Based on the information provided from the customer, this could be the most likely cause of the tear.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.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ALL PURPOSE FOAM ELECTRODES
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 10303750
• Report Number: 9681860-2020-00512
• Device Sequence Number: 13619876
• Product Code: DRX
• UDI-Device Identifier: 10612479182940
• UDI-Public: 10612479182940
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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
• Operator of Device: No Information
• Device Model Number: 87-50SG
• Device Catalogue Number: 87-50SG
• Device Lot Number: 011869
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 07/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other