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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL SINOVIAL SODIUM HYALURONATE FOR INJECTION

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IBSA FARMACEUTICI ITALIA SRL SINOVIAL SODIUM HYALURONATE FOR INJECTION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypoesthesia (2352); Malaise (2359)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
This report describes a foreign case (ibsa ref. N. (b)(4) received for a device (ous tradename sinovial) that is similar to gelsyn-3 approved under pma p110005.
 
Event Description
This serious spontaneous report was received from laboratories genevrier (ref. Nr. (b)(4) on (b)(6) 2020 describes the occurrence of hypoesthesia, malaise and erythema, in a unknown patient who was prescribed sinovial (hyaluronate sodium 0. 8 %), injection, 2 ml for unknown indication. Description: (b)(6) 2019: right knee infiltration around 2 p. M. A month before, the patient had been infiltrated in the left knee with the same products, it was the 3rd infiltration. 1 hour later the patient presented with a feeling of malaise, with significant heat, redness of the face without urticarial flare the next day. While washing she found hypoesthesia of the right hemiface, all over territory of v, without paralysis of the facial nerve vii, having lasted approximately 48 hours. Assessment in emergency room and neuro intensive care without particularity, with an mri scanner, normal biology eliminating a stroke or tumor pathology. Possible assessment for infiltration, but neither likely nor certain. The declaration was made due to the potential severity of the neurological reaction and the lack of reporting of this side effect with this product. The patient was not taking any concomitant medication. The case is considered serious for hospitalization. The patient recovered without sequalae. Ibsa comment: serious, unlisted, possible reaction to infiltration due to lack of alternative explanation. However this could be also a concomitant spontaneous event. On (b)(6) 2020 follow up was received from laboratories genevrier: it is not very clear whether all the symptoms lasted 48 hours or only the hypoesthesia. The case was reported by the crpv (regional center of pv) of toulouse. Ibsa comment: follow up information doesn't change the assessment, serious case, possible, unlisted.
 
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Brand NameSINOVIAL
Type of DeviceSODIUM HYALURONATE FOR INJECTION
Manufacturer (Section D)
IBSA FARMACEUTICI ITALIA SRL
via martiri di cefalonia 2
lodi (san grato), 26900
IT 26900
Manufacturer (Section G)
IBSA FARMACEUTICI ITALIA SRL
via martiri di cefalonia 2
lodi (san grato) 26900
IT 26900
Manufacturer Contact
christopher jones
1050 k street nw
suite 925
washington, dc 
7536475700
MDR Report Key9979404
MDR Text Key192061344
Report Number3008280916-2020-00218
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P110005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2020 Patient Sequence Number: 1
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