MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LECTRODE,ECG,FOAM

Catalog Number	MDS611503A
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient, a male german shepherd, underwent a thoracotomy for surgical ligation of his patent ductus arteriosus (pda) and upon recovery, the patient was placed on the telemetry unit using three electrocardiography (ecg) conductive adhesive electrodes to monitor for rupture or potential hemorrhaging from pda.The electrodes are stored in the original packaging, in the facility storage room, on the intensive care unit (icu) floor in bins for easy access.The electrodes were in place for approximately 36 hours prior to being removed.When the patient was preparing to discharge on, the ecg pads were removed and there was a slight reddening around the sites where the pads were located.The ecg pads have been used on this patient previously to monitor the patient while he was under anesthesia, and no obvious complications were noted during that use.The patient's only known allergy is beef which was not used or ingested by the patient before, during or after the procedure.After the patient was discharged from the hospital the reddened areas that were under the electrodes turned into a 3mm black crusty area with no apparent inflammation in the right armpit area and two areas that were approximately 3 inches apart on the left side that were circular and red.After the patient was discharged from the facility, following his surgery, he was released for follow up with his referring veterinarian.The lesions did not appear for days following the removal of the ecg pads.The patient has had repeated visits to the referring veterinarian and is being treated for moist dermatitis.The sites became infected and the canine was treated with silver sulfadiazine topical ointment and given petmd hot spot skin remedy antibacterial twice a day.The canine was also given galliprant 60mg once daily for 7 days (a nonsteroidal anti-inflammatory drug nsaid) and simplicef 200mg once daily for 14 days (an antibiotic) for the infection that was experienced at the reaction sites.As of 11/14/2018 the lesions on the left side were not completely healed yet; however, the infection has cleared up with the use of antibiotics and nsaids.The exact electrodes used on the canine were discarded at the time of discharge since no issue was seen when the electrodes were removed.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient experienced burns under the electrode pads.

• Common Device Name: LECTRODE,ECG,FOAM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8111013
• Report Number: 1417592-2018-00132
• Device Sequence Number: 19265752
• Product Code: DRX
• UDI-Device Identifier: 10080196317035
• UDI-Public: 10080196317035
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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 Catalogue Number: MDS611503A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 MO
• Patient Weight: 26