MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for PORT DELIVERY SYSTEM manufactured by Genentech.
[183738460]
Pt was hospitalized for pneumonia. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093754 |
| MDR Report Key | 9834798 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-29 |
| Date Added to Maude | 2020-03-16 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORT DELIVERY SYSTEM |
| Generic Name | PORT-A-CATH IMPLANTED, SUBCUTANEOUS INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-03-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENENTECH |
| Brand Name | RANIBIZUMAB 100 MG/ML |
| Product Code | --- |
| Date Received | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | GENENTECH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-13 |