VERMED DEFIB PADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for VERMED DEFIB PADS manufactured by Graphic Controls Acquisition Corp. (vermed Inc.).

Event Text Entries

[142082075] During cardioversion, the patient received 1st degree burn where electrodes were placed. Manufacturer response for defibrillation electrode, multi-function defibrillation electrode (per site reporter): sending label so device can be returned for quality review.
Patient Sequence No: 1, Text Type: D, B5

[142084302] During cardioversion, the patient received 1st degree burn where electrodes were placed. Manufacturer response for defibrillation electrode, multi-function defibrillation electrode (per site reporter): sending label so device can be returned for quality review.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8517675
• MDR Report Key: 8517675
• Date Received: 2019-04-16
• Date of Report: 2019-04-10
• Date of Event: 2019-04-01
• Report Date: 2019-04-10
• Date Reported to FDA: 2019-04-10
• Date Reported to Mfgr: 2019-04-16
• Date Added to Maude: 2019-04-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• 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 Details

• Brand Name: VERMED DEFIB PADS
• Generic Name: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Product Code: MLN
• Date Received: 2019-04-16
• Lot Number: Y111918-06
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: 1 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GRAPHIC CONTROLS ACQUISITION CORP. (VERMED INC.)
• Manufacturer Address: 400 EXCHANGE ST BUFFALO NY 14204 US 14204

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-04-16