REGARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for REGARD manufactured by Resource Optimatization & Innovation, Llc.

Event Text Entries

[125684400] Skin peeling was noted on left medial thigh when the drapes/ioban was pulled off. Skin tear noted on the right scapula from the r2 pad site when pads were taken off. Manufacturer's guidelines were followed when taking off r2 pads. There was sloughing of skin on left inner thigh with regard defibrillator pads.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8024190
• MDR Report Key: 8024190
• Date Received: 2018-10-31
• Date of Report: 2018-10-26
• Date of Event: 2018-10-22
• Report Date: 2018-10-26
• Date Reported to FDA: 2018-10-26
• Date Reported to Mfgr: 2018-10-31
• Date Added to Maude: 2018-10-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: REGARD
• Generic Name: PADS, DEFIBRILLATION
• Product Code: MLN
• Date Received: 2018-10-31
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: RESOURCE OPTIMATIZATION & INNOVATION, LLC
• Manufacturer Address: 3000 E SAWYER RD REPUBLIC MO 65738 US 65738

Device Sequence Number: 1

• Brand Name: REGARD
• Generic Name: PADS, DEFIBRILLATION
• Product Code: OEV
• Date Received: 2018-10-31
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESOURCE OPTIMATIZATION & INNOVATION, LLC
• Manufacturer Address: 3000 E SAWYER RD REPUBLIC MO 65738 US 65738

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-10-31