WEBCOL * 5110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-09 for WEBCOL * 5110 manufactured by Covidien, Formerly Kendall A Division Of Tyco Healthcare.

Event Text Entries

[3792282] This event involves a look-alike product packaging issue that was a near miss. A nurse almost used an adhesive wipe to prep an area. She had intended to use an alcohol wipe but picked up the adhesive by mistake due to the very similar packaging between the adhesive remover and the alcohol prep wipes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3426674
• MDR Report Key: 3426674
• Date Received: 2013-09-09
• Date of Report: 2013-09-09
• Date of Event: 2013-07-16
• Report Date: 2013-09-09
• Date Reported to FDA: 2013-09-09
• Date Reported to Mfgr: 2013-10-24
• Date Added to Maude: 2013-10-24
• 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: 3
• 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: WEBCOL
• Generic Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Product Code: LKB
• Date Received: 2013-09-09
• Returned To Mfg: 2013-07-15
• Model Number: *
• Catalog Number: 5110
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048

Device Sequence Number: 2

• Brand Name: KENDALL ADHESIVE REMOVER
• Generic Name: SOLVENT, ADHESIVE TAPE
• Product Code: KOX
• Date Received: 2013-09-09
• Model Number: *
• Catalog Number: 21480
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DAY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-09-09