MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE (HYALURONIC ACID) INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 21934

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2024

Event Type  malfunction  

Event Description

Durolane (hyaluronic acid) 60mg/3 ml syringe was defective.Provide pulled cap off and the needle hub came off with at the same time, so needle could not be put on the syringe.

• Brand Name: DUROLANE (HYALURONIC ACID) INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 19152354
• MDR Text Key: 341001299
• Report Number: MW5154030
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130-2020-1
• UDI-Public: 89130-2020-1
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 21934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Patient Sequence Number: 1