MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALGAN; HYALURONATE SODIUM

Device Problem Insufficient Information (3190)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

(b)(4).On 28 november 2011, (b)(4).The present mdr report satisfies the reporting obligations for both companies.The case came from eudravigilance (country (b)(6) in which fidia is mah of the product).The patient after the use of the product hyalgan had: arthritis.The case has been deemed as serious by the reporter due to a medical important event.The case has been deemed as serious and expected as an inflammatory reaction ( as pain, swelling/effusion, heat and reddening) is described in the hyalgan smpc.The causality relationship has been evaluated as probable by the company.No new signal alert has been detected.No additional information is required to perform this medical evaluation from the pv physician.

Event Description

This is a spontaneous report by a physician, downloaded by fidia from eudravigilance on (b)(6) 2018 (authority number: (b)(4)).It is a medically confirmed case.This is not the original narrative of the sender.A (b)(6) male patient was treated with hyalgan (sodium (hyaluronate de), by intra-articular route, at the dose of 20 mg daily in (b)(6) 2017, for osteoarthritis knee.In (b)(6) 2017, the patient experienced arthritis.The event was report as serious due to medically important event.Hyalgan was withdrawn.The event was resolved.Reaction as described by the primary source: (b)(6).No concomitant medication was reported.No further information was available.

• Brand Name: HYALGAN
• Type of Device: HYALURONATE SODIUM
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer (Section G): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 7640713
• MDR Text Key: 112430441
• Report Number: 9610200-2018-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P950027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2018
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 65