MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. WOVEN GAUZE SPONGE 4 IN X 4 IN.; GAUZE / SPONGE NONRESORBABLE FOR EXTERNAL USE

Catalog Number	NON21448
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Small brown spot noted on sterile gauze when it was removed from the packaging.No discoloration seen on the packaging.

• Brand Name: WOVEN GAUZE SPONGE 4 IN X 4 IN.
• Common Device Name: GAUZE / SPONGE NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; mundelein IL
• MDR Report Key: 7832213
• Report Number: MW5079480
• Device Sequence Number: 1809074
• Product Code: NAB
• UDI-Device Identifier: 20080196690876
• UDI-Public: (01)20080196690876
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NON21448
• Device Lot Number: 6051710072 044
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 2