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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.

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ANIKA THERAPEUTICS, INC. MONOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION. Back to Search Results
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Insufficient Information (4580)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant investigation.
 
Event Description
It was reported to anika that the device plunger flange broke when the physician was pushing the plunger of the monovisc syringe. It was reported that the physicians finger was cut from the glass. The procedure was cancelled. It is unknown if the physician required medical intervention. Additional information was solicited.
 
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Brand NameMONOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
32 wiggins avenue
bedford MA 01730
MDR Report Key12408943
MDR Text Key272165758
Report Number3007093114-2021-00310
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 Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/01/2021 Patient Sequence Number: 1
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