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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC INJ 88MG/4ML; ACID, HYALURONIC, INTRAARTICULAR

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ANIKA THERAPEUTICS, INC. MONOVISC INJ 88MG/4ML; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 06/19/2018
Event Type  No Answer Provided  
Event Description
Doctor has prescribed monovisc for an injection into the pt's hip.
 
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Brand Name
MONOVISC INJ 88MG/4ML
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
MDR Report Key7637947
MDR Text Key112459477
Report NumberMW5078068
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier59676082001
UDI-Public59676082001
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/25/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age57 YR
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