MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-22 for BANYAN STAT KIT manufactured by Banyan International Corp..
[4359246]
I ordered an emergency medication kit from (b)(6). It was shipped to my office missing 7 medications. I was not notified of the missing items. When i received the kit i discovered it was incomplete. As of today (b)(6) 2013 i am still missing 1 med, 14 months later. I would not have ordered this kit if informed it was missing medications. Kits should not be sold if not complete. This could create a serious situation. Emergency medication kit shipped missing 7 listed medications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035785 |
| MDR Report Key | 3775726 |
| Date Received | 2014-04-22 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-02-18 |
| Date Added to Maude | 2014-04-29 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BANYAN STAT KIT |
| Generic Name | BANYAN STAT KIT |
| Product Code | LRR |
| Date Received | 2014-04-22 |
| Lot Number | 32630 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BANYAN INTERNATIONAL CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-22 |