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

Lot Number DON'T HAVE INFO

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Local Reaction (2035); Swelling (2091); Skin Inflammation (2443)

Event Date 04/04/2019

Event Type  Injury  

Event Description

Durolane injections made knee pain worse than before i received the injections.Returned to dr a week later because of swelling, sore to the touch and warm feeling knees.

• Brand Name: DUROLANE GEL INJECTIONS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 8515126
• MDR Text Key: 142117225
• Report Number: MW5085856
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 04/11/2019

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 Operator: No Information
• Device Lot Number: DON'T HAVE INFO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 68