MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-28 for MUELLER HINTON AGAR W/4% NACL 01-626 manufactured by Remel Co..
[10019]
Failure to grow oxacillin resistant staph aureus on pt isolates or on quality control strains.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003518 |
| MDR Report Key | 16460 |
| Date Received | 1994-09-28 |
| Date of Report | 1994-09-21 |
| Date Added to Maude | 1994-09-29 |
| 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 | 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 | MUELLER HINTON AGAR W/4% NACL |
| Product Code | JTZ |
| Date Received | 1994-09-28 |
| Catalog Number | 01-626 |
| Lot Number | 2942 |
| Device Expiration Date | 1994-09-15 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16393 |
| Manufacturer | REMEL CO. |
| Manufacturer Address | LENEXA KS 66215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-28 |