MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC RWJBH SHOULDER ARTH STD; ORTHOPEDIC TRAY

Catalog Number SOP40SARW7

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

Shoulder lap pack had only 4 instead of the 5 usually present.

• Brand Name: RWJBH SHOULDER ARTH STD
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 18239264
• MDR Text Key: 329481394
• Report Number: MW5148588
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SOP40SARW7
• Device Lot Number: 064645
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male