MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-24 for PACMED manufactured by Aesynt.
[48719984]
Pacmed packaged tablets of crestor and mislabeled them as acetaminophen. Five tablets were dispensed and administered to some combination of 5 patients. The attending physicians of all 5 patients were notified and no harm was reported. (b)(4) was promptly notified and they determined it was a rare timing issue during the canister restocking and the use of the witness feature when an error message is created. Aesynt provided a workaround solution until a permanent one is identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063162 |
| MDR Report Key | 5761318 |
| Date Received | 2016-06-24 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-05-08 |
| Date Added to Maude | 2016-06-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PACMED |
| Generic Name | PACMED |
| Product Code | NXB |
| Date Received | 2016-06-24 |
| ID Number | ARP-400SL6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-24 |