NO STING BARRIER FILM E7506

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-12 for NO STING BARRIER FILM E7506 manufactured by Cavilon.

Event Text Entries

[3968364] Pt underwent a radio frequency cardiac ablation. Later that day, she reported that her back was wet. She had a blister at the place where the grounding pad had been placed. Over time, that area developed into a deep burn. The pt was hospitalized and the area was debrided. Dates of use: (b)(6) 2013. Diagnosis or reason for use: grounding pads were not sticking. Event abated after use stopped: #1 yes and #2 yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5033431
MDR Report Key	3523023
Date Received	2013-12-12
Date of Report	2013-12-11
Date of Event	2013-10-03
Date Added to Maude	2013-12-17
Event Key	0
Report Source Code	Voluntary 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	0
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	NO STING BARRIER FILM
Generic Name	NO STING BARRIER FILM
Product Code	KOY
Date Received	2013-12-12
Catalog Number	E7506
Lot Number	NHRIC8333-3343
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Sequence No	1
Device Event Key	0
Manufacturer	CAVILON
Manufacturer Address	ST. PAUL MN 55144 US 55144

Device Sequence Number: 2

Brand Name	NON-REM POLYHESIVE ELECTRODE
Generic Name	POLYHESIVE
Product Code	GEI
Date Received	2013-12-12
Catalog Number	E7506
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Sequence No	2
Device Event Key	0
Manufacturer	COVIDIEN VALLEY LAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2013-12-12