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

Model Number	MDT2168284
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, disposable or towels were transferring lint to eye muscle and clinging to suture which needed to be cleaned out.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.There was no medical intervention or serious injury originally reported related to this event.However, due to the reported nature of the incident, the need for medical intervention, and in abundance of caution this medwatch is being filed.Samples have not been returned for evaluation.No further information is available.If any further relevant information is identified or obtained a supplemental medwatch will be filed.
Event or Problem Description
It was reported, disposable or towels were transferring lint to eye muscle and clinging to suture which needed to be cleaned out.

• Brand Name: MEDLINE
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,STD,4/PK,20PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10578076
• Report Number: 1417592-2020-00102
• Device Sequence Number: 2682689
• Product Code: FRL
• UDI-Device Identifier: 10080196282739
• UDI-Public: 10080196282739
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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 Model Number: MDT2168284
• Device Catalogue Number: MDT2168284
• Device Lot Number: 8432002003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/23/2020
• 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: Required Intervention