MAUDE Adverse Event Report: BIOVENTUS LLC GEL INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Headache (1880); Pain (1994); Burning Sensation (2146); Malaise (2359); Numbness (2415); Sleep Dysfunction (2517)

Event Date 10/06/2023

Event Type  Injury  

Event Description

Reporter calling, stating she received a "gel injection" in her left knee to treat arthritis.Reporter states she was injected on (b)(6) 2023, and afterwards experienced some pain and difficulty walking, however, there was no redness nor discoloration in her knee, so she dismissed these initial symptoms.Reporter states that "ten days later" she began experiencing headaches and general malaise.Reporter states she sought treatment with her pcp (primary care physician) and discussed her recent gel injection in her left knee, however reporter states her pcp was not concerned that the injection was the cause of her symptoms.Reporter states the headaches continued to persist, however, and she additionally began experiencing "my hands feel like they are on fire", numbness, and burning sensations in her hands and feet.Reporter states her symptoms are "worse at night" and "i haven't slept in months" due to them.Reporter states she called bioventus on (b)(6) 2023 to report all the symptoms she was experiencing, however she states that they were dismissive of her concerns.Reporter states she has had numerous calls "back and forth" with bioventus since and states they are denying problems with their product.Reporter states she is frustrated regarding her symptoms and "no answers from bioventus" as to their cause.Reporter states she has had "numerous" tests at her doctor's office to rule out other causes of her symptoms and states that all these other tests are negative.Reporter states "i regret getting this" and states she is urging others to avoid getting this type of injection.

• Brand Name: GEL INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 18384477
• MDR Text Key: 331346025
• Report Number: MW5149489
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female