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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE PFS ACID, HYALURONIC, INTRAARTICULAR

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BIOVENTUS LLC DUROLANE PFS ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Event Description
Patient had inflammatory reaction (had an adverse reaction to durolane) md is switching patient to euflexxa, no more information directions; inject one syringe intra-particularly to bilateral knees one time at the physician¿s office. Indication: bilateral primary osteoarthritis of knee. Reported to (b)(6)/caremark by: patient/caregiver.
 
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Brand NameDUROLANE PFS
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key13026194
MDR Text Key282605767
Report NumberMW5106147
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/06/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes

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