MAUDE Adverse Event Report: BIOVENTUS SUPARTZ STRENGTH: 25MG/2.5ML; SODIUM HYALURONATE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Arthralgia (2355); Reaction (2414)

Event Date 01/23/2018

Event Type  Injury  

Event Description

S/w pt - 1st injection of supartz was (b)(6) 2018 after this injection not really a problem, but after the 2nd injection on (b)(6) 2018, the injection was very painful and she had very bad pain in both knees and has had extreme swelling and pain.She has even had to take pain medication, which usually does not have to do.Her worst day after the injection on the (b)(6) was friday; (b)(6) 2018, she goes back for 3rd injection tomorrow and is going to question her md about the pain/swelling that she is experiencing to see if he sees this in other pts, or if she is having an adverse reaction to supartz.She had had euflexxa a couple of years ago and did not have the same reaction to it.

• Brand Name: SUPARTZ STRENGTH: 25MG/2.5ML
• Type of Device: SODIUM HYALURONATE
• Manufacturer (Section D): BIOVENTUS
• MDR Report Key: 7251062
• MDR Text Key: 99578107
• Report Number: MW5075129
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/05/2018

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR