• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANIKA THERAPEUTICS, INC. MONOVISC SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)
Patient Problem No Code Available (3191)
Event Date 12/07/2018
Event Type  Injury  
Manufacturer Narrative
In the medwatch letter, the physician stated that the device was being used off label. There was no adverse event or serious injury reported in the notification letter.
 
Event Description
Doctor has prescribed the medication to be injected into hip. Dates of use (b)(6) 2018; diagnosis or reason for use: m16, 12; is the product compounded? no; is the product over the counter? no.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMONOVISC
Type of DeviceSODIUM HYALOURONATE 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
rebecca obeng
32 wiggins ave
bedford, MA 01730
7814579500
MDR Report Key8236066
MDR Text Key132825516
Report Number3007093114-2018-00019
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P090031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2018
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 Unkown

Patient Treatment Data
Date Received: 01/10/2019 Patient Sequence Number: 1
-
-