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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYMOVIS HIGH MOLECULAR WEIGHT VISCOELASTIC HYALURONAN - INTRAARTICULAR HYALURONIC ACID

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FIDIA FARMACEUTICI S.P.A. HYMOVIS HIGH MOLECULAR WEIGHT VISCOELASTIC HYALURONAN - INTRAARTICULAR HYALURONIC ACID Back to Search Results
Catalog Number 89122-0496-63
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Bacterial Infection (1735); Sepsis (2067); Renal Impairment (4499)
Event Type  Injury  
Event Description
On (b)(6) 2020 an (b)(6)-year-old male patient was treated with hymovis (hyaluronate sodium hexadecylamine) gel for injection, via intra-articular route, at the dose of 1 injection to both the right and the left knee. The product batch number was: d05600 (expiry date: 16/01/2023). The patient experienced streptococcal sepsis and renal insufficiency due to a suspected product quality issue. At the time of the reporting the outcome was not resolved. Reaction as described by the primary source: following the injection, a reaction developed: sepsis due to streptococcal infection. The patient with kidney and heart problems was admitted to intensive care, having decompensation due to renal insufficiency. Medical analysis revealed the diagnosis of streptococcus. No concomitant medication was not reported. Medical history include: kidney disorder and heart disorder. Results of the product quality control of the involved batch: no anomaly was found. Based on the performed investigation, the reported adverse event is not related to a possible defect of the product quality. No further information is available.
 
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Brand NameHYMOVIS
Type of DeviceHIGH MOLECULAR WEIGHT VISCOELASTIC HYALURONAN - INTRAARTICULAR HYALURONIC ACID
Manufacturer (Section G)
FIDIA FARMACEUTICI S.P.A.
via ponte della fabbrica 3a
abano terme, pd 35031
IT 35031
Manufacturer Contact
giuseppe di sante
via ponte della fabbrica 3a
abano terme, pd 35031
IT   35031
MDR Report Key11384764
MDR Text Key233742704
Report Number9610200-2021-00002
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number89122-0496-63
Device Lot NumberD05600
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/26/2021 Patient Sequence Number: 1
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