HYMOVIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for HYMOVIS manufactured by Fidia Pharma Usa, Inc.

Event Text Entries

[181784421] Received hymovis injections (bi-lateral) and suffered severe side effects requiring an er visit & several knee aspirations to remove excessive fluids (over 200cc's). After the second injection i felt physically ill, dizzy/nauseous, etc. Additionally, my knee pain became severe enough that i could no longer walk unassisted. My knees became swollen, painful & felt unsteady. I have used several fiscal supplements in the past with positive effects. I had moderate arthritis but after using hymovis it feels like it drastically sped the arthritic process of both of my knees. This product should be immediately removed from the market.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5093397
MDR Report Key	9774592
Date Received	2020-02-28
Date of Report	2020-02-26
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	3
Previous Use Code	3
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	HYMOVIS
Generic Name	ACID, HYALURONIC, INTRA ARTICULAR
Product Code	MOZ
Date Received	2020-02-28
Device Availability	Y
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	FIDIA PHARMA USA, INC

Device Sequence Number: 2

Brand Name	HYMOVIS
Generic Name	ACID, HYALURONIC, INTRA ARTICULAR
Product Code	MOZ
Date Received	2020-02-28
Device Availability	Y
Device Eval'ed by Mfgr	*
Device Sequence No	2
Device Event Key	0
Manufacturer	FIDIA PHARMA USA, INC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2020-02-28