MAUDE Adverse Event Report: ANIKA MONOVISC; SODIUM HALURONATE FOR INTRA ARTICULAR INJECTION

Catalog Number MONOVISC, 4 ML, US - 690016

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 the fda reported mw 5101289 to (b)(6).The reported event is as follows: patient's orthopedic surgeon injected monovisc into the patients left knee to treat steoarthritis.Five minutes after the injection, the patient experienced swellin and edema in the lips and throat.The patient took benadryl and the symptoms were resolved.Additional information was solicited.

Manufacturer Narrative

The reported event is not confirmed.Additional information was not provided upon solicitation.The lot number is unknown.A review of the batch record could not be performed.A supplemental report will be submitted upon receipt of new and relevant information.This event will be monitored for trending.

Event Description

On 27 may 2021, the fda reported to mw5101289 anika.The reported event is as follows: patient's orthopedic surgeon injected monovisc into the patient's left knee to treat steoarthritis.Fives minutes after the inject, the patient experienced swelling and edema in the lips and throat.The patient took benadryl and the symptoms resolved after 90 minutes.There was no reported medical intervention required.Additional information was not provided upon solicitation.See h10 for the plant investigation.

• Brand Name: MONOVISC
• Type of Device: SODIUM HALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12127294
• MDR Text Key: 260225220
• Report Number: 3007093114-2021-00122
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MONOVISC, 4 ML, US - 690016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MW5101289
• Patient Sequence Number: 1