MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; DRAPE, SURGICAL, EXEMPT

Model Number	DYNJP7002
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Upon closing count the nurse discovered a single strand of hair clinging to one of the sterile lap sponges of medline thyroid surgical drape.All staff including patient were wearing a hair covering.

• Brand Name: MEDLINE
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11504467
• Report Number: 11504467
• Device Sequence Number: 3843911
• Product Code: PUI
• UDI-Device Identifier: 10080196736508
• UDI-Public: (01)10080196736508
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021
• Report Date (Section F): 03/05/2021

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: No Information
• Device Model Number: DYNJP7002
• Device Catalogue Number: DYNJP7002
• Device Lot Number: 3992010013
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 57
• Date Report Sent to FDA: 03/05/2021