MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BASIC ORTHO PACK; ORTHOPEDIC TRAY

Model Number DYNJ49369

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

Medline basic ortho tray contained only 4 of the indicated 5 sponges.Fda safety report id # (b)(4).

• Brand Name: BASIC ORTHO PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; IL 60093
• MDR Report Key: 11372389
• MDR Text Key: 233526158
• Report Number: MW5099592
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): Y
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DYNJ49369
• Device Catalogue Number: DYNJ49369
• Device Lot Number: 20EBL449
• 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
• Patient Age: 92 YR