MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-04 for SUSCEPTIBILITY CARD manufactured by Vitek Systems, Inc..
[21392132]
The cards are used by the microbiology lab. The cards test for susceptibility of the organism to the sensitivity of the antibiotic. In 10/93, the drug cefazolin was demonstrated as being sensitive to the organism, pseudomonas aeruginosa. Theoretically, this first generation cephalosporin, cefazolin, is not sensitive to this organsim.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000960 |
| MDR Report Key | 11841 |
| Date Received | 1994-03-04 |
| Date of Report | 1994-03-01 |
| Date Added to Maude | 1994-03-07 |
| 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 |
| 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 | SUSCEPTIBILITY CARD |
| Generic Name | VITEK SUSCEPTIBILITY CARDS |
| Product Code | LTW |
| Date Received | 1994-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11841 |
| Manufacturer | VITEK SYSTEMS, INC. |
| Manufacturer Address | HAZELWOOD MO 630422391 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-04 |