MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-08 for URICULT 1000/001-02/93-1000 manufactured by Orion Diagnostica, Inc..
[19140039]
When the device is received from the distributor there is moisture in the containers and melting of the media.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004349 |
| MDR Report Key | 18274 |
| Date Received | 1994-12-08 |
| Date of Report | 1994-11-22 |
| Date of Event | 1994-11-09 |
| Date Added to Maude | 1994-12-09 |
| 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 | URICULT |
| Generic Name | BACTERIA DETECTION |
| Product Code | JSC |
| Date Received | 1994-12-08 |
| Catalog Number | 1000/001-02/93-1000 |
| Lot Number | UH024 |
| Device Expiration Date | 1995-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18202 |
| Manufacturer | ORION DIAGNOSTICA, INC. |
| Manufacturer Address | SOMERSET NJ 08875 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-12-08 |