IOBAN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-27 for IOBAN * manufactured by 3m Healthcare.

Event Text Entries

[21399950] The patient is a 52 year-old male with vascular disease who underwent a distal left sfa to posterior tibial artery bypass for ischemic rest pain and tissue loss to the left lower extremity. The patient's groin and bilateral lower extremities were prepped with duraprep and allowed to dry. An ioban drape was applied. When it was removed, a skin tear occurred on the left medial upper thigh measuring 4 cm x 4 cm. Bacitracin ointment was applied and the wound was covered with tegaderm. The patient was seen in clinic with a non-healing wound, and is being referred to plastic surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1398734
• MDR Report Key: 1398734
• Date Received: 2009-05-27
• Date of Report: 2009-05-27
• Date of Event: 2009-04-28
• Report Date: 2009-05-27
• Date Reported to FDA: 2009-05-27
• Date Added to Maude: 2009-06-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: IOBAN
• Generic Name: DRAPE, SURGICAL, STERILE
• Product Code: KKX
• Date Received: 2009-05-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: 3M HEALTHCARE
• Manufacturer Address: 3M CENTER BLDG 275-4W-02 ST PAUL MN 55144100 US 55144 1000

Device Sequence Number: 2

• Brand Name: PREVAIL
• Generic Name: PREP SOLUTION
• Product Code: KOY
• Date Received: 2009-05-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention	2009-05-27