MAUDE Adverse Event Report: CARDINAL HEALTH PRESOURCE; TRAY, ORTHOPEDIC

Model Number SOP56EX20E

Device Problem Device Packaging Compromised (2916)

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

Event Date 02/01/2018

Event Type  malfunction  

Event Description

There was a hole in my upper extremity pack.It was noticed before we started the case so the table was broken down.We reset everything back up with a new pack and new supplies.

• Brand Name: PRESOURCE
• Type of Device: TRAY, ORTHOPEDIC
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan rd.; waukegan IL 60085
• MDR Report Key: 7263065
• MDR Text Key: 99799898
• Report Number: 7263065
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SOP56EX20E
• Device Catalogue Number: SOP56EX20E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1