MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-20 for RPG ANTIBODY * 7007418 manufactured by Atlantic Antibodies.
[113480]
Infection after contact w/cancer diagnostic process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012686 |
| MDR Report Key | 139758 |
| Date Received | 1997-12-20 |
| Date of Report | 1997-12-20 |
| Date of Event | 1997-12-19 |
| 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 | RPG ANTIBODY |
| Generic Name | DIAGNOSTIC MATERIAL |
| Product Code | DBL |
| Date Received | 1997-12-20 |
| Model Number | * |
| Catalog Number | 7007418 |
| Lot Number | 626 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 136448 |
| Manufacturer | ATLANTIC ANTIBODIES |
| Manufacturer Address | RTE. 1 BOX 751 SCARBOROUGH ME 04074 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-20 |