MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN TOTAL KNEE PACK; ORTHOPEDIC TRAY

Model Number DYNJ9018254

Device Problem Material Puncture/Hole (1504)

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

Event Date 12/10/2019

Event Type  malfunction  

Event Description

Medline total knee pack with hole in the inner drape, wrapped around basin, discovered when removing from sterile pack.The area with the hole was facing inward against the rest of the pack, the outer package integrity remained intact so this was not caused by a hole through the outer packaging.Fda safety report id # (b)(4).

• Brand Name: TOTAL KNEE PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN ; northfield IL 60093
• MDR Report Key: 9496179
• MDR Text Key: 172242703
• Report Number: MW5091765
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: DYNJ9018254
• Device Catalogue Number: DYNJ9018254
• Device Lot Number: 19IBL459
• 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