MAUDE Adverse Event Report: COVIDIEN ELECTRODE PEDIATRIC LIMB BAND L 36LB; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	EP30016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
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 a baby less than 26 weeks gestational age at birth and less than a week old the day of the event had what looked like a chemical burn.The nurse stated that redness was noted when they moved the electrode and the burn was noted within an hour of the electrode being relocated from the affected area.The nurse stated they changed the leads at least 1-2 times per shift due to the high humidity environment.Per additional information received, the customer reported that the patient received nystatin after mepilex or hydrofera blue for treatment.
Additional Manufacturer Narrative
The device history record 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 complain therefore a product examination was not possible, and the reported condition could not be confirmed as a manufacturing issue.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 PEDIATRIC LIMB BAND L 36LB
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque KYG 2 Y7; CA KYG 2Y7
• MDR Report Key: 12455510
• Report Number: 9681860-2021-00520
• Device Sequence Number: 16455029
• Product Code: DRX
• UDI-Device Identifier: 20884527005069
• UDI-Public: 20884527005069
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: Health Professional
• Device Model Number: EP30016
• Device Catalogue Number: EP30016
• Device Lot Number: 107416X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other