• 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 HYALAURONATE 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 HYALAURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Joint Swelling (2356)
Event Date 10/23/2019
Event Type  Injury  
Event Description
"it was reported by the sales rep email that on (b)(6), 2019 the dr. Injected monovisc injections on both knees of a (b)(6) male patient with ra and djd of the knees. On (b)(6), 2019 while the dr was out of town and did not get to see the patient, the patient presented with unilateral knee pain and swelling (synovial fluid wbc 77,000 with cppd crystals) possible pseudosepsis. Although, the patient also had a temp of 102 and 1 of 2 bottles (blood culture) showed coag + staph. The following day his synovial fluid culture was also positive for rare staph, sensitive to most standard antibiotics. The patient was admitted, seen by ortho and the knee was irrigated, he was placed on antibiotic coverage and uneventfully discharged. At this time lot numbers could not be provided for the monoviscs that were used. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMONOVISC
Type of DeviceSODIUM HYALAURONATE FOR INTRA-ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS INC
32 wiggins ave
bedford 01730
Manufacturer Contact
rebecca obeng
32 wiggins ave
bedford 01730
7814579000
MDR Report Key9457397
MDR Text Key186613270
Report Number3007093114-2019-00009
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
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
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/12/2019 Patient Sequence Number: 1
-
-