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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA MONOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.

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ANIKA MONOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION. Back to Search Results
Device Problem Lack of Effect (4065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
The reported event is not confirmed.Additional information was not provided.The lot number is unknown.A batch record review was not performed.All product manufactured by anika and anika entities are released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.
 
Event Description
This complaint is in scope of a complaint remediation project and has been identified as a complaint that required a mdr based on either the source of the complaint or the type of complaint and is being reported.This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 11june2019 the fda reported to anika medwatch (mw5087187) which reported that a patient of an unknown age and demographic had a minimal response to the monovisc injections.There was no negative patient impact reported.There was no report of a malfunction.The lot number was not provided.The status of the patient is unknown.
 
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Brand Name
MONOVISC
Type of Device
SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
Manufacturer (Section D)
ANIKA
32 wiggins avenue
bedford MA 01730
Manufacturer Contact
keith kelly
32 wiggins avenue
bedford, MA 01730
MDR Report Key16981610
MDR Text Key315768030
Report Number3007093114-2023-00019
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 Other
Reporter Occupation Other
Type of Report Initial
Report Date 05/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received06/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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