MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-03 for QUICK RX * manufactured by Quick Rx.
[340735]
Heat sealer used to package compounded unit dose respiratory meds (albuterol-ipratropium budesonide etc. ) malfunctioned causing vials to open and contents leak out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030183 |
| MDR Report Key | 496776 |
| Date Received | 2003-11-03 |
| Date of Report | 2003-11-03 |
| Date of Event | 2003-10-01 |
| Date Added to Maude | 2003-11-24 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICK RX |
| Generic Name | HEAT SEALER |
| Product Code | KSD |
| Date Received | 2003-11-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 485508 |
| Manufacturer | QUICK RX |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-03 |