MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-14 for BAYYAN STAT KIT manufactured by Banyan.
[4417340]
I ordered a banyan stat emergency medication kit 32630. It was shipped with 7 missing medications. Today (b)(6) 2014, fourteen months later i still have not received all items to complete this kit. I was not notified it had back ordered items. I would not have placed the order for an incomplete emergency medication kit. I discovered the missing items when i opened the kit. It seems inappropriate for an emergency medication kit to be sold missing medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035655 |
| MDR Report Key | 3757097 |
| Date Received | 2014-04-14 |
| Date of Report | 2014-04-11 |
| Date of Event | 2013-02-18 |
| Date Added to Maude | 2014-04-18 |
| 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 | 3 |
| 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 | BAYYAN STAT KIT |
| Generic Name | EMERGENCY MEDICATION KIT |
| Product Code | LRR |
| Date Received | 2014-04-14 |
| Lot Number | 32630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BANYAN |
| Manufacturer Address | PALANTINE TX 60055 US 60055 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-14 |