REGARD C100AC-PHYSIO 335561REG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for REGARD C100AC-PHYSIO 335561REG manufactured by Resource Optimization & Innovation, L.l.c..

Event Text Entries

[125482792] Noted a skin tear on the left lateral back and right upper scapula area after gently removing the r2 pads. Visible skin marks on the pads. Lot # y013118-01, model 335561reg, monophasic or biphasic compatible defibrillation cardioversion pacing ecg monitoring electrodes, manufacturer regard. Comparable to physio-control quick-combo electrode. Product not available for return.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8018514
• MDR Report Key: 8018514
• Date Received: 2018-10-30
• Date of Report: 2018-10-26
• Date of Event: 2018-09-05
• Report Date: 2018-10-26
• Date Reported to FDA: 2018-10-26
• Date Reported to Mfgr: 2018-10-30
• Date Added to Maude: 2018-10-30
• 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: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Product Code: MLN
• Date Received: 2018-10-30
• Model Number: C100AC-PHYSIO
• Catalog Number: 335561REG
• Lot Number: Y013118-01
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Manufacturer Address: 3000 E SAWYER RD REPUBLIC MO 65738 US 65738

Device Sequence Number: 1

• Brand Name: REGARD
• Generic Name: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Product Code: OEV
• Date Received: 2018-10-30
• Model Number: C100AC-PHYSIO
• Catalog Number: 335561REG
• Lot Number: Y013118-01
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Manufacturer Address: 3000 E SAWYER RD REPUBLIC MO 65738 US 65738

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-10-30