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

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.

• Brand Name: SINOVIAL
• Type of Device: SODIUM 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 Key: 9979404
• MDR Text Key: 192061344
• Report Number: 3008280916-2020-00218
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P110005
• Number of Events Reported: 1
• 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 Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization