MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TOWEL,OR,DSP,NS,BLUE,BULK,100/CS

Model Number	MDT216801
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the end-user facility that lint from the towel is transferring into the wound during breast surgery.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No sample is available to be returned to the manufacturer.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported by the end-user facility that lint from the towel is transferring into the wound during breast surgery.

• Brand Name: MEDLINE
• Common Device Name: TOWEL,OR,DSP,NS,BLUE,BULK,100/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 12665712
• Report Number: 1417592-2021-00197
• Device Sequence Number: 11884493
• Product Code: FRL
• UDI-Device Identifier: 10080196743414
• UDI-Public: 10080196743414
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MDT216801
• Device Catalogue Number: MDT216801
• Device Lot Number: 6052002037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other