MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE 60MG/3ML PFS INJ ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

Event Type  Injury  

Event Description

Pt only received 1 syringe instead of 2 syringes due to a system error.

• Brand Name: DUROLANE 60MG/3ML PFS INJ
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 9362822
• MDR Text Key: 167767949
• Report Number: MW5091240
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130202001
• UDI-Public: 89130202001
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 89 YR