MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE; HYALURONIC ACID

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Bruise/Contusion (1754); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient contracted cellulitis after her durolane injection.Patient was initially injected on (b)(6) 2025 and immediately experienced pain, swelling, and bruising.On (b)(6) 2025 patient was seen by dr.(b)(6) who prescribed her cephalexin 500mg 4 times a day for 7 days.On the same day the patient goes to emergency room and was given toradol for pain and cefrixone for cellulitis.Patient proved positive for gram a negative bacteria (cellulitis).Patient was released after 7 hours.Patient is currently taking doxycycline for a total of 3 days.
Additional Manufacturer Narrative
It was reported, a patient injected with durolane experienced pain, swelling, and bruising immediately following the injection.The patient returned for a follow up visit to their physician and they were prescribed cephalexin.Patient was in severe pain and went to the emergency room the same day.The patient was diagnosed with cellulitis and had cultures taken, which identified gram a negative bacteria.The patient was given a shot of toradol for the pain and an intravenous antibiotic, ceftriaxone.The patient was released after 7 hours, they were additionally prescribed doxycycline.Patient is currently reported to be improving.A batch record review was completed and confirmed this lot met all specifications prior to release.A final assessment from clinical affairs will be completed upon review of lab test results and batch record review.

• Brand Name: DUROLANE
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): BIOVENTUS LLC; 4721 emperor blvd; suite 100; durham NC 27703
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala, swe SWE-7 52 2; SW SWE-752 28
• Manufacturer Contact: lizzie fields ; 4721 emperor blvd; suite 100; durham, NC 27703 ; 9194746802
• MDR Report Key: 21861597
• Report Number: 3009595577-2025-00004
• Device Sequence Number: 17314609
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: 00816986020808
• Combination Product (Y/N): N
• PMA/510(K) Number: P170007/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1082013
• Device Lot Number: 22489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White