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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 08/26/2020
Event Type  Injury  
Manufacturer Narrative
Attempts for additional information have be unsuccessful to date.Base on the limited information available, no conclusions can be made in regards to the reported event.
 
Event Description
On (b)(6) 2020, the physician assistant reported an adverse event in a female patient that he injected with bilateral durolane injections for osteoarthritis in the knees in (b)(6) 2020.An unknown amount of time post-injection, she developed injection site pain and skin changes and/or discolorations commensurate with nicolau syndrome.The patient was provided unknown treatment, and her current status is unknown at the time of this report.Based on the information available, the root cause of the reported event is most likely related to a very rare embolic event from the intraarticular cavity to the skin.
 
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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 Key10563853
MDR Text Key207901437
Report Number3009595577-2020-00008
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier00816986020808
UDI-Public00816986020808
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 08/26/2020,09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number1082020
Device Catalogue Number1082020
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date08/26/2020
Date Report to Manufacturer08/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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