DURAPREP * 8630

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-22 for DURAPREP * 8630 manufactured by 3m Healthcare.

Event Text Entries

[17073569] Patient with intact skin underwent surgical prep with duraprep for foot surgery. Ioban steri-drape placed over prepped skin. When steri-drape attempted to be removed after the initial portion of the procedure, patient's skin was blistered and peeled off with the steri-drape. When the foot was examined, additional areas on the foot blistered where duraprep used. The procedure was terminated at that point. 3m remover lotion was used by the surgeon to gently remove the remaining duraprep from the patient's skin. Dorsal foot with denuded area. Large toe and sole of foot with denuded areas.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1397567
• MDR Report Key: 1397567
• Date Received: 2009-05-22
• Date of Report: 2009-05-22
• Date of Event: 2009-05-22
• Report Date: 2009-05-22
• Date Reported to FDA: 2009-05-22
• Date Added to Maude: 2009-06-04
• 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: DURAPREP
• Generic Name: PREP SOLUTION
• Product Code: KOY
• Date Received: 2009-05-22
• Model Number: *
• Catalog Number: 8630
• Lot Number: 2012-02AJ1
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: 3M HEALTHCARE
• Manufacturer Address: 3M CENTER ST. PAUL MN 55144 US 55144

Device Sequence Number: 2

• Brand Name: IOBAN 2
• Generic Name: DRAPE, ANTIMICROBIAL
• Product Code: KKX
• Date Received: 2009-05-22
• Model Number: *
• Catalog Number: 6640EZ
• Lot Number: 2011-02 CD
• ID Number: *
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: 3M HEALTHCARE
• Manufacturer Address: 3M CENTER ST. PAUL MN 55144100 US 55144 1000

Device Sequence Number: 3

• Brand Name: *
• Generic Name: DRAPE, ANTIMICROBIAL
• Product Code: KKX
• Date Received: 2009-05-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: 3M HEALTH CARE
• Manufacturer Address: 3 M CENTER BLDG 275-4W-02 ST. PAUL MN 55144100 US 55144 1000

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-05-22