ALTRAZEAL TRANSFORMING POWDER DRESSING WITH NANOFLEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-15 for ALTRAZEAL TRANSFORMING POWDER DRESSING WITH NANOFLEX manufactured by Uluru Inc, Aplus Secure Packaging.

Event Text Entries

[3002447] Product, altrazeal transforming dressing marketed by uluru, inc. (b)(4), and produced by a+ secure packaging as (b)(4). I believe the product is not marketed under the correct designation. Further, the product appears to dissociate after application and form small particles. The company scientist insists that the product does not fall apart, however a test of the powder which transforms from a powder into an intact film, in saline at our office shows that tiny particles do float free from the material. Further, the product is described as a nanoflex technology by the company and packaging. When asked about the material, the sales rep indicated that the product was developed with nanotechnology but after formation did not have any nanoparticles specifically in it. Requests for testing showed some microscope images but the company did not indicate that they had a dialogue with the fda on the product, only that it met all safety requirements. The company was unaware on the draft guidance of considering whether the fda-regulated product involved the application of nanotechnology.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5027706
• MDR Report Key: 2847067
• Date Received: 2012-11-15
• Date of Report: 2012-11-15
• Date of Event: 2011-10-15
• Date Added to Maude: 2012-11-28
• 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
• 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 Details

• Brand Name: ALTRAZEAL TRANSFORMING POWDER DRESSING WITH NANOFLEX
• Generic Name: ALTRAZEAL 5GM
• Product Code: NAE
• Date Received: 2012-11-15
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ULURU INC, APLUS SECURE PACKAGING

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-11-15