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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
Model Number 690-016
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
Event Type  malfunction  
Event Description
On 30sept2021 it was reported to anika that during a knee injection, the monovisc syringe broke. There was no art of the syringe touching the patient. There was no patient impact reported. A replacement monovisc syringe was used to complete the treatment. There was no reported delay to the procedure. Additional information was solicited.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant investigation.
 
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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 Key12864347
MDR Text Key282624367
Report Number3007093114-2021-00314
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
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number690-016
Device Catalogue Number690018
Device Lot Number0000005505
Was Device Available for Evaluation? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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