MAUDE Adverse Event Report: FIDIA FARMACEUTICI SPA HYALGAN; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Fatigue (1849); Pain (1994); Foreign Body In Patient (2687)

Event Date 12/01/2023

Event Type  Injury  

Event Description

Reporter calling to report experiencing intense pain as well as being "bedridden" after receiving hyalgan injection in his left knee.Reporter states he receives treatment at a (b)(6).Reporter states he was treated by a p.A.(physician's assistant) who performed the injection on approximately (b)(6) 2023.Reporter states that "about two days" after the injection, he experienced intense pain and was unable to walk, and was confined to his bed.Reporter states he is scheduled for knee replacement in a few months, however he wonders how he is going to manage until then due to ongoing pain he is experiencing.Reporter states that at the time of the injection, the p.A.Told him some of the hyalgan may have been inadvertently placed in his "soft knee tissue" as the needle was being withdrawn, however reporter states the p.A.Told him that this would be absorbed by the body after a brief period of time.

• Brand Name: HYALGAN
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FIDIA FARMACEUTICI SPA
• MDR Report Key: 18676037
• MDR Text Key: 335118063
• Report Number: MW5151224
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2024

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Patient Sequence Number: 1
• Treatment: ORAL PAIN MEDICATIONS; STEROID INJECTIONS FOR PAIN
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male