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

Catalog Number	89122-0724-20
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
This is a spontaneous report received by (b)(4), initial importer for and wholly owned subsidiary of fidia farmaceutici (b)(4) as reported by (b)(6) specialty pharmacy to the importer and fda, (fda mw5087768).A (b)(6) year old female patient was treated with hyalgan 20mg/2ml (hyaluronate sodium) solution for inarticular injection, 20mg weekly starting (b)(6) 2018.Device lot number was b09850, expiry 26-jul-2020.On an unspecified date the patient stated her left knee started to hurt.The initial report indicated the patient outcome of the adverse event was hospitalization.The event was reported as serious due to hospitalization.The primary source described the event as "patient informed her left knee started to hurt".

• Brand Name: HYALGAN
• Common Device Name: HYALURONATE SODIUM
• Manufacturer (Section D): FIDIA FARMACEUTICI, S.P.A.; via ponte della fabbrica, 3/a; abano terme, 35031 ; IT 35031
• MDR Report Key: 8817888
• Report Number: 3009107511-2019-00007
• Device Sequence Number: 16945469
• Product Code: MOZ
• UDI-Device Identifier: M71389122072420A1
• UDI-Public: M71389122072420A1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019
• Report Date (Section F): 07/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: 89122-0724-20
• Device Lot Number: B09850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Date Report Sent to FDA: 07/02/2019