MAUDE Adverse Event Report: SYNCHRONIS MEDICAL REGARD; ADULT/CHILD DEFIBRILLATION ELECTRODE

Model Number	315711REG
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Skin Tears (2516); Blister (4537); Skin Burning Sensation (4540)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
When zoll pads were placed on the patient he complained of extreme burning and itching.He tried to pull them off.They took one off which was red outside the outline of the pad but not the second and it caused a blister that later became a tear.The skin was dry, they did not shave and she wasn't sure if they prepped the skin before placement.

• Brand Name: REGARD
• Common Device Name: ADULT/CHILD DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): SYNCHRONIS MEDICAL; 4401 varsity dr. ste d; ann arbor MI 48108
• Manufacturer (Section G): RESOURCE OPTIMIZATION & INNOVATION, LLC; 645 maryville centre drive; ste 200; st. louis MO 63141
• Manufacturer Contact: cheyenne stewart ; 645 maryville centre drive; ste 200; st. louis, MO 63141 ; 4176473205
• MDR Report Key: 13006454
• Report Number: 3004513970-2021-00001
• Device Sequence Number: 20042631
• Product Code: MLN
• UDI-Device Identifier: 00326053105494
• UDI-Public: 00326053105494
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 315711REG
• Device Catalogue Number: 315711REG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown