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

Lot Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Muscular Rigidity (1968); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

This report was originally filed on 22feb2017 on the test server.The account was approved and moved to the production server on (b)(4)2017.I was informed to resubmit all previous files to the production server.Production account approval help desk ticket #(b)(4).Notification of moving files to production account help desk ticket #(b)(4).

Event Description

The following is an exact copy of the reported issue: outcome: not recovered/not resolved.Event description: initial, domestic, spontaneous case was reported on (b)(6)2017 by a female patient of unknown age who received monovisc (hyaluronate sodium) for an unknown indication.Patient's other relevant medical history and concomitant medications were not reported.In (b)(6)2016, patient received an injection of monovisc.Exact dosage and site of administration were not specified.Patient reported that her knee was swollen/still swollen/constantly swollen and hot to the touch.Her shins, ankle and feet were still swelling regularly.There was tightness behind the knee and she was not able to bend.There was tightness in the muscles.The shins were so tight and the bottom below her knee felt like there was water running down the inside of it and that feeling had been there since she had the injection.Patient also mentioned that she experienced some hives like blisters but they were gone/resolved.There was a general unwell feeling and a trouble sleeping.Patient was enquiring whether there was something she could do for the side effects, when they might dissipate/go away on their own.Patient had been back to see her doctor who thought that it was highly unlikely that it was the monovisc that was causing the side effects.Additional information was received on (b)(6)2017 from patient patient's concomitant medications included advil for pain.Patient confirmed that she did not see any improvement at all in the pain she was feeling since she received the injection.The site of injection was still very tender to the touch.Patient also clarified that the hives she experienced were all over her body, on her arms and chest.She got them right after the injection and it lasted for 2 weeks.Patient's outcome was ongoing at the time of this report.No further information available.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: armando botelho ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 6786608
• MDR Text Key: 82453508
• Report Number: 3007093114-2017-00005
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): N
• PMA/PMN Number: P090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other