EUFLEXXA

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5093675
MDR Report Key9818547
Date Received2020-03-10
Date of Report2020-03-09
Date of Event2020-03-01
Date Added to Maude2020-03-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameEUFLEXXA
Generic NameACID, HYALURONIC INTRAARTICULAR
Product CodeMOZ
Date Received2020-03-10
Lot NumberN16870A
Device Expiration Date2019-09-02
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerFERRING PHARMACEUTICALS INC. /BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.

Device Sequence Number: 101

Brand Name10 MG/ML - MILLIGRAMS PER MILLILITRES
Product Code---
Date Received2020-03-10
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-10

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