MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML manufactured by Ferring Pharmaceuticals, Inc..
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Patient called in stating that she has been having hives for an extended time 1 to 1. 5 years, she has been using euflexxa with positive results and they are trying to rule out potential causes for patient? S hives. She reports she has an egg and soy allergy.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5093431 |
MDR Report Key | 9775243 |
Date Received | 2020-02-28 |
Date of Report | 2020-02-27 |
Date of Event | 2020-02-27 |
Date Added to Maude | 2020-03-02 |
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 1% SOLUTION FOR INJECTION 10MG/1ML |
Generic Name | ACID, HYALURONIC, INTRAARTICULAR |
Product Code | MOZ |
Date Received | 2020-02-28 |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | FERRING PHARMACEUTICALS, INC. |
Product Code | --- |
Date Received | 2020-02-28 |
Device Sequence No | 101 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-28 |