MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-22 for BCYE SELECTIVE WITH PAV * manufactured by Hardy Diagnostics.
[17835135]
Legionella medium bcye + pav, lot 05112 does not support the growth of l. Pneumophila. Mfr was notified in may, but has sent the same lot as replacement three times, the last time today.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035867 |
| MDR Report Key | 753196 |
| Date Received | 2005-06-22 |
| Date of Report | 2005-06-22 |
| Date Added to Maude | 2006-08-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BCYE SELECTIVE WITH PAV |
| Generic Name | BACTERIOLOGIC MEDIUM |
| Product Code | JSJ |
| Date Received | 2005-06-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 05112 |
| ID Number | * |
| Device Expiration Date | 2005-07-01 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 740998 |
| Manufacturer | HARDY DIAGNOSTICS |
| Manufacturer Address | * SANTA MARIA CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-22 |