MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE UNIVERSITY LOU TOTAL KNEE PACK; GENERAL SURGERY TRAY

Catalog Number CMPJO5341G

Device Problems Structural Problem (2506); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2020

Event Type  malfunction  

Event Description

Light handle covers do not sit flush with light.They flip up at edges.Fda safety report id #: (b)(4).

• Brand Name: MEDLINE UNIVERSITY LOU TOTAL KNEE PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10179463
• MDR Text Key: 196201607
• Report Number: MW5095128
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CMPJO5341G
• Device Lot Number: 20BBC676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1