DISPOSABLE BURN SHEET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-06 for DISPOSABLE BURN SHEET manufactured by Matrix Medical, Inc..

Event Text Entries

[14479] Rptr feels burn sheet is defective and represents a potential danger to pts. Rptr is a full time faculty member of a medical school dept of emergency medicine and medical director for the physician and surgeon ambulance service. Director of operations, brought to his attention that the burn sheet disintegrates in its plastic wrapper. The material appears to be paper, and when removed from its plastic wrapper is accompanied by a fine dust which could easily be inhaled (particularly in the setting of a pt with a substantial burn) and it appears to be innapropriate cover for any burned surface. Rptr was told that the city health dept, which is responsible for inspection of ambulances, was aware this product is defective and they would not certify ambulances for use based upon this product's presence on the unit. Director of operations attempted to contact the co about the defect but was told that the product in their warehouse was not defective and that they would not remove and replace this product. Rptr personally observed the dissintegration of this product in two separate new cases. The disintegration of this product could not only delay and complicate the appropriate care of the pt but potentially could be inhaled by a pt with a compromised upper airway.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4000868
• MDR Report Key: 27443
• Date Received: 1995-10-06
• Date of Report: 1995-01-24
• Date of Event: 1995-01-01
• Date Added to Maude: 1995-10-25
• 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: 0
• 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: DISPOSABLE BURN SHEET
• Generic Name: DISPOSABLE BURN SHEET
• Product Code: FPY
• Date Received: 1995-10-06
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 28337
• Manufacturer: MATRIX MEDICAL, INC.
• Manufacturer Address: 145 MD COUNTY DR. ORCHARD PARK NY 14127 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1995-10-06