MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for EUFLEXXA manufactured by Ferring Pharmaceuticals Inc. /bio-technology General (israel) Ltd..
[183341139]
Pt reported being taken by ambulance to the hospital due to having blood pressure issues. Pt experienced catheterization and had a stress test performed as well. Arxwp has not filled this med recently.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5093675 |
MDR Report Key | 9818547 |
Date Received | 2020-03-10 |
Date of Report | 2020-03-09 |
Date of Event | 2020-03-01 |
Date Added to Maude | 2020-03-11 |
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 |
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 | EUFLEXXA |
Generic Name | ACID, HYALURONIC INTRAARTICULAR |
Product Code | MOZ |
Date Received | 2020-03-10 |
Lot Number | N16870A |
Device Expiration Date | 2019-09-02 |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | FERRING PHARMACEUTICALS INC. /BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. |
Brand Name | 10 MG/ML - MILLIGRAMS PER MILLILITRES |
Product Code | --- |
Date Received | 2020-03-10 |
Device Sequence No | 101 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2020-03-10 |