* MDS202000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-26 for * MDS202000 manufactured by Medline Industries, Inc..

Event Text Entries

[4074035] At the start of the laparoscopic appendectomy, as usual, the surgeon cleaned the opening of the trocar with the cotton tipped applicator to remove blood for a clearer visual. The cotton tip slipped off of the wooden handle and fell inside the abdomen. The surgeon successfully retrieved it. It does not appear as if the glue bonding the cotton tip to the wooden handle is strong enough to keep it intact. The staff has tested several applicators from several lot numbers including the ones put into our packs and they are all equally easily removed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3556546
• MDR Report Key: 3556546
• Date Received: 2013-11-26
• Date of Report: 2013-11-26
• Date of Event: 2013-10-22
• Report Date: 2013-11-26
• Date Reported to FDA: 2013-11-26
• Date Reported to Mfgr: 2014-01-07
• Date Added to Maude: 2014-01-07
• 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: *
• Generic Name: COTTON TIPPED APPLICATOR
• Product Code: KXG
• Date Received: 2013-11-26
• Model Number: MDS202000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Manufacturer Address: ONE MEDLINE PLACE MUNDELEIN, IL 60060 IL 60060 US 60060

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-11-26