MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOWEL,OR,DSP,ST,NATURAL,DLX,4/PK,20PK/CS

Catalog Number	MDT2168284N
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by end user that product sterile disposable natural o.R."towels have a lot of lint in them causing shedding into the wounds." despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported nature of this incident and in an abundance of caution, this medwatch is filed.Samples have not been returned therefore a root cause has not been determined at this time.No further information is available.If additional relevant information becomes available, this report will be reopened and reevaluated.
Event or Problem Description
It has been reported, "the towel have a lot of lint in them causing shedding into the wounds.".

• Common Device Name: TOWEL,OR,DSP,ST,NATURAL,DLX,4/PK,20PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10512156
• Report Number: 1417592-2020-00101
• Device Sequence Number: 2962564
• Product Code: FRL
• UDI-Device Identifier: 10884389109908
• UDI-Public: 10884389109908
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: MDT2168284N
• Device Lot Number: 2601912003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/09/2020
• 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