MAUDE Adverse Event Report: MCKESSON MCKESSON CONNECT

Device Problems Packaging Problem (3007); Data Problem (3196)

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

Event Type  Other  

Event Description

Description: there are two different info of cyclosporine marketed in the us.Cyclosporine and cyclosporine modified.They are not generically interchangeable.We had a mix up in our pharmacy that was caught as we were putting the product on our shelf that we order from (b)(6).We believe the less than optimum description in mckesson connect contributed to this.As you can see from the copy of the mfr's box this product ((b)(6)) in attachment the product name is "cyclosporine capsules usp modified".This is true also for all the other products listed that are actually "modified" formulation.(b)(4).

• Brand Name: MCKESSON CONNECT
• Type of Device: MCKESSON CONNECT
• Manufacturer (Section D): MCKESSON
• MDR Report Key: 5353652
• MDR Text Key: 35546055
• Report Number: MW5059084
• Device Sequence Number: 1
• Product Code: NZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1