MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-06 for MCKESSON CONNECT manufactured by Mckesson.
[35546055]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059084 |
| MDR Report Key | 5353652 |
| Date Received | 2016-01-06 |
| Date of Report | 2015-11-20 |
| Date Added to Maude | 2016-01-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCKESSON CONNECT |
| Generic Name | MCKESSON CONNECT |
| Product Code | NZH |
| Date Received | 2016-01-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCKESSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-06 |