MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - LAREDO BASIC ORTHO TRAY LARGE SPONGES / BASIC ORTHO TRAY; ORTHOPEDIC TRAY

Model Number DYNJ49369

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

The blue radiopaque strips separated at the sponge of 2 of 5 large sponges in the basic ortho tray.Fda safety report id # (b)(4).

• Brand Name: BASIC ORTHO TRAY LARGE SPONGES / BASIC ORTHO TRAY
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - LAREDO ; northfield IL 60093
• MDR Report Key: 11648200
• MDR Text Key: 245336754
• Report Number: MW5100701
• Device Sequence Number: 1
• Product Code: OJH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: DYNJ49369
• Device Catalogue Number: DYNJ49369
• Device Lot Number: 20JBC475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2021
• 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
• Patient Age: 66 YR