MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-13 for MRSA SCREEN AGAR 4321952 manufactured by Becton Dickinson Microbiology Systems.
[94026]
The user had several mrsa isolates come up as susceptible on mrsa screen agar. Vitek results were reported as >8, which indicates resistance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1998-00003 |
| MDR Report Key | 156930 |
| Report Source | 05,06 |
| Date Received | 1998-03-13 |
| Date of Report | 1998-03-02 |
| Date of Event | 1998-02-02 |
| Date Mfgr Received | 1998-02-02 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 1998-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRSA SCREEN AGAR |
| Generic Name | PREPARED PLATED MEDIA |
| Product Code | JTZ |
| Date Received | 1998-03-13 |
| Model Number | NA |
| Catalog Number | 4321952 |
| Lot Number | B1NHIM |
| ID Number | * |
| Device Expiration Date | 1998-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 152878 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Baseline Brand Name | MRSA SCREEN AGAR |
| Baseline Generic Name | PREPARED PLATED MEDIA |
| Baseline Model No | NA |
| Baseline Catalog No | 4321952 |
| Baseline ID | G3NXXL |
| Baseline Device Family | PREPARED PLATED MEDIA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 3 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K863821 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1998-03-13 |