BIOCLUSIVE OCCLUSIVE FILM DRESSING *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-04 for BIOCLUSIVE OCCLUSIVE FILM DRESSING * manufactured by Johnson & Johnson Ethicon.

Event Text Entries

[16399343] Pt has reaction to bioclusive at two sites, right hip and left forearm developed blisters at application site witin 6-8 hours after application.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034329
• MDR Report Key: 566096
• Date Received: 2005-01-04
• Date of Report: 2005-01-03
• Date of Event: 2004-12-06
• Date Added to Maude: 2005-01-19
• 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: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOCLUSIVE OCCLUSIVE FILM DRESSING
• Generic Name: *
• Product Code: MGQ
• Date Received: 2005-01-04
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 555882
• Manufacturer: JOHNSON & JOHNSON ETHICON
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-01-04