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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 03/09/2023

Event Type  Injury  

Event Description

This is a serious case downloaded from eudravigilance on (b)(6) 2023 (authority number (b)(4)); reported by pharmacist.This case comes from "faro" study.On unknown date a 65-year-old female patient started kenacort (triamcinolone) at the dose of 40 milligrams for investigation.On (b)(6) 2023 patient started hyalgan (sodium hyaluronate) for investigation.Medical history was not provided.Reactions: on (b)(6) 2023, the patient developed dyspnea.The outcome of the event was reported to be recovering/resolving.No actions were taken regarding the event.According to the reporter the event was judged as other medically important condition.On (b)(6) 2023, the patient developed allergic reaction to drug.The outcome of the event was reported to be recovering/resolving.No actions were taken regarding the event.According to the reporter the event was judged as other medically important condition.On (b)(6) 2023, the patient developed rash pruritic.The outcome of the event was reported to be recovering/resolving.No actions were taken regarding the event.According to the reporter the event was judged as other medically important condition.Reactions as reported by primary source: dyspnea; allergic reaction after kenacort and hyalgan infiltration; itchy generalized skin rash.No further information is available.

• Brand Name: HYALGAN
• Type of Device: SODIUM HYALURONATE
• 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: giuseppina lo castro ; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 17036871
• MDR Text Key: 316290811
• Report Number: 9610200-2023-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: KENACORT.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female