MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TOTAL KNEE PROCEDURE [PACK]; ORTHOPEDIC TRAY

Model Number CMPJ05911

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Medline total knee procedure pack only had 4 of the 5 indicated lap sponges.Fda safety report id# (b)(4).

• Brand Name: TOTAL KNEE PROCEDURE [PACK]
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 12134624
• MDR Text Key: 260604368
• Report Number: MW5102329
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMPJ05911
• Device Catalogue Number: CMPJ05911
• Device Lot Number: (10)20WBG777
• 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: 74 YR