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

MAUDE Adverse Event Report: ORTHOVISC INJ 15G 1ML ACID, HYALURONIC, INTRAARTICULAR

  • 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
 

ORTHOVISC INJ 15G 1ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Arthritis (1723); Joint Disorder (2373)
Event Date 05/02/2017
Event Type  Injury  
Event Description
Notified of recent hospitalization from insurance claims. Diagnosis for admission: m17:11 - unilateral primary osteoarthritis right knee. No outreach by cm. Is the product compounded: no. Is the product over-the-counter: no.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORTHOVISC INJ 15G 1ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
MDR Report Key6551192
MDR Text Key74720647
Report NumberMW5069604
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-