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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.
 
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.Additional information was not provided upon request.See h10 for plant investigation.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant investigation.The device was not returned to the manufacturing plant for evaluation.Additional information was not provided upon request.The batch records were reviewed.There were two non-conformances recorded in the manufacturing records.The non-conformances are not related to the reported event.This reported event will be monitored and trended for analysis.A supplemental report will be submitted upon receipt of new and relevant information.
 
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Brand Name
MONOVISC
Type of Device
SODIUM 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
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
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 Health Professional
Device Expiration Date03/31/2023
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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