MAUDE Adverse Event Report: BIOVENTUS LLC SUPARTZ EX 25MG/2.5 ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Use of Device Problem (1670)

Patient Problems Inflammation (1932); Pain (1994); Swelling/ Edema (4577)

Event Date 04/10/2023

Event Type  Injury  

Event Description

Reporter feels the physician¿s assistant injected too far back, swelling, inflammation, pain.Pt said she got supartz shot (b)(6) 2023 but she feels the pa injected too far back on the outside of the left knee and she still has pain and inflammation a month later.It is tender and the mdo told her to take meloxicam but she took one dose and it did not seem to work so she takes advil and tried ice packs.She even slept with ice packs on her knee but it is still swollen.Reference reports mw5117885, mw5117886.

• Brand Name: SUPARTZ EX 25MG/2.5 ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 17009800
• MDR Text Key: 316149477
• Report Number: MW5117884
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: LOSARTAN, MELOXICAM, ADVIL.
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 58 KG