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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 N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Pain (1994); Rash (2033); Swelling/ Edema (4577)
Event Date 12/29/2023
Event Type  Injury  
Event Description
It was reported a patient injected with the durolane product experienced a rash on the lateral side of the left knee.The patient also had pain and swelling at the injection site.The symptoms began two days post injection.The patient had a follow up with the clinic a month after the injection and was treated for bruising at the injection site.The symptoms continued and the patient went to the emergency room.The patient was diagnosed with nicolau syndrome and admitted to the hospital.The patient underwent a debridement of the area and was prescribed vancomycin and ceftin.The current patient status is unknown and it was reported the patient will have an additional follow up procedure, a skin graft, which has not yet been completed.
 
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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 Key18816128
MDR Text Key336657091
Report Number3009595577-2024-00001
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 Nurse
Type of Report Initial
Report Date 02/07/2024,02/06/2024
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 Health Professional
Device Model NumberN/A
Device Catalogue Number1082020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/06/2024
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/07/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/01/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
Patient SexMale
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