SPONGE, NONWOVEN, DRAIN, 4" X 4", STERILE * NON256000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1999-02-09 for SPONGE, NONWOVEN, DRAIN, 4" X 4", STERILE * NON256000 manufactured by Medline Industries, Inc..

Event Text Entries

[155234] Reportedly the gauze sponges are fraying at the split and it is possible that parts of the sponge may fall into the trach. No medical attention was required.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1417592-1999-00005
• MDR Report Key: 209643
• Report Source: 08
• Date Received: 1999-02-09
• Date of Report: 1999-01-08
• Date of Event: 1998-10-14
• Date Facility Aware: 1999-01-08
• Report Date: 1999-02-09
• Date Reported to FDA: 1999-02-09
• Date Reported to Mfgr: 1999-02-09
• Date Added to Maude: 1999-02-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SPONGE, NONWOVEN, DRAIN, 4" X 4", STERILE
• Generic Name: GAUZE SPONGE
• Product Code: GER
• Date Received: 1999-02-09
• Model Number: *
• Catalog Number: NON256000
• Lot Number: 219812
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 203455
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Manufacturer Address: ONE MEDLINE PL. MUNDELEIN IL 60060 US
• Baseline Brand Name: SPONGE, NONWOVEN, DRAIN, 4" X 4", STERILE
• Baseline Generic Name: GAUZE SPONGE
• Baseline Model No: *
• Baseline Catalog No: NON256000
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-02-09