MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-10 for GONOGON 50 DETERMINATING * manufactured by Bbl.
[19105]
The test kit was opened on 6/27/95. There was no reagent in the staff control bottle which is used to determine false positive reactions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000899 |
| MDR Report Key | 27094 |
| Date Received | 1995-10-10 |
| Date of Report | 1995-03-24 |
| Date Added to Maude | 1995-10-17 |
| 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 | GONOGON 50 DETERMINATING |
| Generic Name | GONOGON 50 DETERMINATING |
| Product Code | JSX |
| Date Received | 1995-10-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 27889 |
| Manufacturer | BBL |
| Manufacturer Address | * COCKEYVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-10-10 |