MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - LAREDO TOTAL HIP [PACK]; ORTHOPEDIC TRAY

Model Number DYNJ901823

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2021

Event Type  malfunction  

Event Description

Only 4 of 5 large sponges contained in the "total hip" pack.Fda safety report id# (b)(4).

• Brand Name: TOTAL HIP [PACK]
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - LAREDO ; northfield IL 60093
• MDR Report Key: 11664013
• MDR Text Key: 245577807
• Report Number: MW5100762
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: DYNJ901823
• Device Catalogue Number: DYNJ901823
• Device Lot Number: 21ABL020
• 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: 90 YR