MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC; SODIUM HALURONATE FOR INTRA ARTICULAR INJECTION

Catalog Number 690016

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant investigation.

Event Description

The following was reported to the fda on mw5101085: an unspecified white substance or particle was observed in the syringe.Additional information was solicited.

Event Description

The following was reported to the fda on mw5101085: an unspecified white substance or paticle was observed in the syringe.Additional information was solicited.See h10 for manufacturing evaluation.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant investigation.Additional information was not provided upon solicitation.The reported event is not confirmed.A review of the batch record was performed.There was no non-conformances or deviations in the manufacturing record.This case will be re-assessed and a supplemental report will be submitted upon receipt of new and relevant information.The reported event will be monitored and trended for analysis.

• Brand Name: MONOVISC
• Type of Device: SODIUM HALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12125649
• MDR Text Key: 262562224
• Report Number: 3007093114-2021-00180
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 690016
• Device Lot Number: 4864
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MW5101085
• Patient Sequence Number: 1