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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE 60MG3ML PFS INJ ACID, HYALURONIC, INTRAARTICULAR

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BIOVENTUS LLC DUROLANE 60MG3ML PFS INJ ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2019
Event Type  Injury  
Event Description
Provider is aware that durolane is being used outside of mfr guidelines for injection into shoulder. Medication is indicated for injection into the knees.
 
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Brand NameDUROLANE 60MG3ML PFS INJ
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key8777173
MDR Text Key150842974
Report NumberMW5088008
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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