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 2010-03-04 for DURAPREP * 8630 manufactured by 3m.

Event Text Entries

[1484974] The patient was prepped and draped for an esophagastrectomy. Staff used duraprep to initially prep the site. During the procedure, the surgeon determined that he needed to access an additional area on the neck and requested that the surgical field be expanded. The drape was cut and the expanded field was prepped with duraprep (catalog # 8630--26ml). Staff report that the field was dry and that sterile towels were used to wall off the edges of the expanded surgical field. Because the surgical site was on the neck, a clear barrier was not put down. The surgeon used a blade to extend the incision followed by a bovie to cauterize bleeders. The surgeon reports that immediately after, he felt his finger burning and staff report seeing a flame on the field. The surgeon began to pat out the flame and the staff immediately poured normal saline on the site. The patient sustained first and second degree burns on the neck (redness and blisters). Wound care evaluated the patient and recommended a topical cream. The patient's hospitalization was not extended from this event and he has since been discharged to an extended care facility. There was no apparent scarring and the skin healed well. The surgeon's hand had a first degree burn and required no medical treatment. The operating room team believes that fumes from the prep were caught in the drapes, which ignited when the bovie was activated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1628167
• MDR Report Key: 1628167
• Date Received: 2010-03-04
• Date of Report: 2010-03-04
• Date of Event: 2010-02-08
• Report Date: 2010-03-04
• Date Reported to FDA: 2010-03-04
• Date Added to Maude: 2010-03-11
• 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 Details

• Brand Name: DURAPREP
• Generic Name: PREP SOLUTION, SURGICAL
• Product Code: KOY
• Date Received: 2010-03-04
• Model Number: *
• Catalog Number: 8630
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: 3M
• Manufacturer Address: 3M CENTER, BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2010-03-04