MAUDE Adverse Event Report: BIOVENTUS / SEIKAGAKU COPORATION, TAKAHAGI PLANT SUPARTZ FX; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyanosis (1798); Inflammation (1932); Pain (1994); Swelling (2091); Injury (2348)

Event Date 07/22/2020

Event Type  Injury  

Event Description

Had a torn meniscus and dr gave me "prolozone" on (b)(6) followed by supartz injections on (b)(6).I received 10 shots to inner side of knee and one shot on outer side.My knee swelled up and turned back and blue for 5 weeks.A vein was punctured and blood squirted out of the holes.The inner side of the knee now had spider vein that i hope will eventually worsen.I visited the doctor, he assured me this was normal.It is supposed to cause inflammation.The meniscus in healing with info i found on the internet, however, the shots to the knee are still causing some pain with the vein that was compromised.Needless to say, i cancelled the remaining 10 injection.The doctor said 10 shots, it may have been too aggressive.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS / SEIKAGAKU COPORATION, TAKAHAGI PLANT
• MDR Report Key: 10634311
• MDR Text Key: 210197847
• Report Number: MW5097075
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 09/22/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1