DRESSING CHANGE TRAY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-30 for DRESSING CHANGE TRAY * manufactured by Tri-state Hosp Supply Corp.

Event Text Entries

[409851] Sorbaview dressing applied to provide coverage of picc line insertion site. Pt called to report "bloody dressing" the next day. Registered nurse visited that evening to assess the dressing and perform an aseptic dressing change. Upon nurse's arrival she noted "dollar size blood clots on wing of picc and continued bleeding on surrounding skin", in addition pt had picc arm wrapped with ice collar. The nurse removed the dressing and attempted to cleanse the area of the blood to determine the origin of the bleeding. The pt began to complain of extreme discomfort when the nurse applied antiseptic applicator -chloraprep- contained within package, nurse then noted "skin worn off. " the affected area was immediately wrapped with sterile gauze and pt sent to emergency room for eval. Possible degradation of skin secondary to product usage.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1035089
• MDR Report Key: 588489
• Date Received: 2005-03-30
• Date of Report: 2005-03-30
• Date Added to Maude: 2005-04-08
• 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: DRESSING CHANGE TRAY
• Generic Name: *
• Product Code: MCY
• Date Received: 2005-03-30
• Model Number: *
• Catalog Number: *
• Lot Number: 901035
• ID Number: *
• Device Expiration Date: 2007-09-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 578340
• Manufacturer: TRI-STATE HOSP SUPPLY CORP
• Manufacturer Address: 301 CATRELL HOWELL MI 48843 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-03-30