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

Model Number DYNJ901823

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2021

Event Type  malfunction  

Event Description

Two (2) medline total hip procedure and total hip packs with compromised (holes) in the table cover upon opening of the sterile pack.The clear, outside dust cover was intact for both packs.Fda safety report id# (b)(4).

• Brand Name: TOTAL HIP PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 11790067
• MDR Text Key: 249749355
• Report Number: MW5101230
• 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: 05/05/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ901823
• Device Catalogue Number: DYNJ901823
• Device Lot Number: 21ABL238
• Was Device Available for Evaluation?: No
• 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: 30 YR