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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Q-MED AB DUROLANE HYALURONIC ACID
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Q-MED AB DUROLANE HYALURONIC ACID Back to Search Results
Model Number 1082020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Date 11/01/2019
Event Type  Injury  
Event Description
On 10 june 2020, the physician reported an adverse event in a female patient that he injected with durolane for osteoarthritis in the knee in (b)(6) 2019. One month post-injection, she developed skin changes and/or discolorations commensurate with nicolau syndrome. A subsequent skin biopsy showed ha particles in the microvasculature. The patient was successfully treated with hyaluronidase in the dermatology department. All skin discolorations disappeared without further problems. Based on the information available, the root cause of the reported event is most likely related to a very rare embolic event from the intra-articular cavity to the skin.
 
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Brand NameDUROLANE
Type of DeviceHYALURONIC ACID
Manufacturer (Section D)
Q-MED AB
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
MDR Report Key10242179
MDR Text Key202705775
Report Number3009595577-2020-00007
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/10/2020,07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1082020
Device Catalogue Number1082020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date06/10/2020
Event Location No Information
Date Report to Manufacturer06/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/07/2020 Patient Sequence Number: 1
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