MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. PREMIUM DRY TRAY LF; GENERAL SURGERY TRAY

Model Number	DYND70661
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medline premium dry tray lf sterile paper wrap noted to have a 3" slit.Fda safety report id # (b)(4).

• Brand Name: PREMIUM DRY TRAY LF
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; northfield IL 60093
• MDR Report Key: 12934760
• Report Number: MW5105820
• Device Sequence Number: 1728276
• Product Code: LRO
• UDI-Device Identifier: 10080196998593
• UDI-Public: (01)10080196998593
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: Health Professional
• Device Model Number: DYND70661
• Device Catalogue Number: DYND70661
• Device Lot Number: (10)21HBD123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White