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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
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ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION Back to Search Results
Catalog Number 630254
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Manufacturer Narrative
This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
 
Event Description
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 28feb2024 the distributor reported to anika that an orthovisc syringe plunger broke during the injection.It is unknown if the glass syringe broke during the injection.There was no negative patient or user impact reported.There was no report of any unusual appearance with the device or packaging prior to use.Additional information was solicited.
 
Manufacturer Narrative
This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.The reported event is not confirmed.It was reported that the plunger broke during a procured on a patient of unknown age and demographics.There was no negative patient or user impact reported.The device was not returned to the manufacturing plant for analysis.The lot number is unknown.A review of the batch record could not be performed.All product manufactured by anika is released to applicable procedures and specifications.A three-year retrospective review of nonconformances for the product was performed.There was no nonconformances related to the reported event.A three-year retrospective review of the retention inspection was performed.There was no nonconformances related to the reported event documented in the logs.A review of the stability study report for (orthovisc) was performed.There was no nonconformances documented in the stability study report.The conclusion for the product stated that the product has met all required specifications and tolerances.A supplemental report will be submitted upon receipt of new and relevant information.The reported event will continue to be monitored and trended for future analysis.
 
Event Description
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 (b)(6) 2024 the distributor reported to anika that an orthovisc syringe plunger broke during the injection.It is unknown if the glass syringe broke during the injection.There was no negative patient or user impact reported.There was no report of any unusual appearance with the device or packaging prior to use.Additional information was solicited.
 
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Brand Name
ORTHOVISC
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 Key18934282
MDR Text Key338556153
Report Number3007093114-2024-00004
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 Other
Type of Report Initial,Followup
Report Date 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number630254
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/11/2024
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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