MAUDE Adverse Event Report: Q-MED AB DUROLANE; HYALURONIC ACID

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Necrosis (1971)

Event Date 01/25/2021

Event Type  Injury  

Event Description

A woman in her 60s with a medical history of osteoarthritis presented with a one-week history of a mildly pruritic and tender lesion on the left lateral knee.The patient had received a hyaluronic acid injection one month prior to the same knee for osteoarthritis.The patient noticed worsened symptoms in cold temperatures or with pressure.Physical examination revealed a 9 cm x 8 cm erythematous to violaceous reticular, partially blanchable patch on the left lateral knee (figure 1).On examination, the patient was well-appearing and afebrile.A punch biopsy was performed (figure 2, 3).Microscopic examination showed epidermal necrosis (figure 2) and bluish material, consistent with hyaluronic acid, occluding vessels in the dermis (figure 3, 4).A diagnosis of hyaluronic acid embolus was rendered.The patient was given 130 units of hyaluronidase injected into the left lateral knee.Immediate improvement of pain and discoloration was observed.Subsequent 150 and 300 units of hyaluronidase were injected at 60-minute intervals.The patient was advised to continue massaging and elevating leg with the goal of decreasing remaining erythema.

• Brand Name: DUROLANE
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): Q-MED AB; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 15702946
• MDR Text Key: 302760128
• Report Number: 3009595577-2022-00003
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1082020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female