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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Malaise (2359); Respiratory Arrest (4461); Reaction to Medicinal Component of Device (4574)

Event Date 07/16/2021

Event Type  Injury  

Event Description

A (b)(6) year-old female patient used 1 dose of hyalgan (hyaluronate sodium) via intra-articular route, for osteoarthritis, on (b)(6) 2021 and diprostene (betamethasone dipropionate; betamethasone sodium phosphate) unknown pharmaceutical form, at unknown dose, for unknown indication.On the same date, the patient experienced malaise and respiratory arrest.At the time of the reporting, the outcome was resolved.Reaction as described by the primary source: after the injection of a corticosteroid (diprostene) + hyalgan, the patient presented with malaise followed by respiratory arrest.Concomitant medication: algicare (anti-inflammatory food supplement); algesic plus (paracetamol+codeine); aléogine (a harpagophytum-based gel) medical history: asthmatic patient.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, 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: 12834274
• MDR Text Key: 280933625
• Report Number: 9610200-2021-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: TS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 10/19/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIPROSTENEALGESIC PLUS
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female