MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-11 for GONAGEN CONFIRMATION TEST FOR NEISSERIA GONORRHOEA 434000 manufactured by Becton Dickinson Microbiology Systems.
[16979]
The sheath control reagent bottle used to detect false positive reactions was empty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006470 |
| MDR Report Key | 23330 |
| Date Received | 1995-07-11 |
| Date of Report | 1995-06-28 |
| Date Added to Maude | 1995-07-11 |
| 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 | GONAGEN CONFIRMATION TEST FOR NEISSERIA GONORRHOEA |
| Generic Name | CONFIRMATION TEST |
| Product Code | LTS |
| Date Received | 1995-07-11 |
| Catalog Number | 434000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23618 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-07-11 |