MAUDE Adverse Event Report: BIOVENTUS LLC. DUROLANE 60MG/3ML MG MILLIGRAM(S); ACID, HYALURONIC, INTRAARTICULAR

Lot Number	19754
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medication was injected as directed.Patient experienced severe pain for 4 days following the injection.Did eventually subside, but am seeing this happen in quite a few patients.Diagnosis for use: osteoarthritis, pain- bilateral knee.

• Brand Name: DUROLANE 60MG/3ML MG MILLIGRAM(S)
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 13633935
• Report Number: MW5107767
• Device Sequence Number: 12066085
• Product Code: MOZ
• UDI-Device Identifier: 89130-2020-1
• UDI-Public: 89130-2020-1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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 Expiration Date: 06/30/2024
• Device Lot Number: 19754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIDOCAINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 144 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White