MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-18 for URICULT manufactured by Orion Diagnostica.
[12423]
Postmark date: 5/12/95
Patient Sequence No: 1, Text Type: D, B5
[15523]
Lot #uk039. Co has determine they were exposed to adverse temperature either during shipping or storage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005655 |
| MDR Report Key | 21236 |
| Date Received | 1995-04-18 |
| Date Added to Maude | 1995-04-19 |
| 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 | URICULT |
| Product Code | JSC |
| Date Received | 1995-04-18 |
| Lot Number | UK 039 |
| Device Expiration Date | 1995-04-12 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21221 |
| Manufacturer | ORION DIAGNOSTICA |
| Manufacturer Address | SOMERSET NJ 08875 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-04-18 |