MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-20 for WHITE/ALB 10081 WHITE/GEL manufactured by Jackson Lab..
[77759]
Kit provided to perform serum test not functional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012688 |
| MDR Report Key | 139767 |
| Date Received | 1997-12-20 |
| Date of Report | 1997-12-20 |
| Date of Event | 1997-12-18 |
| Date Added to Maude | 1997-12-29 |
| 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 | WHITE/ALB 10081 |
| Generic Name | SERUM DIAGNOSTIC TEST KIT |
| Product Code | DCF |
| Date Received | 1997-12-20 |
| Model Number | WHITE/GEL |
| Catalog Number | 10081 |
| Lot Number | 1298 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 136457 |
| Manufacturer | JACKSON LAB. |
| Manufacturer Address | 600 MAIN ST. BAR HARBOR ME 04609 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-20 |