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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIDIA PHARMA USA HYMOVIS INJ 24MG/3ML ACID, HYALURONIC, INTRAARTICULAR

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FIDIA PHARMA USA HYMOVIS INJ 24MG/3ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 06/06/2019
Event Type  Injury  
Event Description
Doctor wrote prescription for injecting into alternating knees weekly for a total of 4 weeks. I advised this is atypical, dosing is usually weekly for 2 weeks into bilateral knees (if both knees are to be treated) and dr's office confirmed to continue with atypical dosing.
 
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Brand NameHYMOVIS INJ 24MG/3ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FIDIA PHARMA USA
florham park NJ
MDR Report Key8696582
MDR Text Key148066100
Report NumberMW5087338
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 06/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2019
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
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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