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

Model Number 226748

Device Problems Product Quality Problem (1506); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

Many surgeons are complaining about the dual-tip markers from medline.They don¿t mark in the eye and approximately three are opened in each case because they run out of ink.

• Brand Name: MEDLINE
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13168010
• MDR Text Key: 283245299
• Report Number: 13168010
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 226748
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other