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

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 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
 

FERRING PHARMACEUTICALS INC. EUFLEXXA ACID HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Cramp(s) (2193)
Event Date 05/31/2018
Event Type  Injury  
Event Description
Severe cramp in the calf after my second injection, painful to where i was crying and my two boys had to rub the cramp out of my calf. Lasted for 3-4 mins, very painful. Told physician, he stated the injection has nothing to do with the cramping. I disagree, i've never had a calf cramping before. Date the person first started taking or using the product: (b)(6) 2018, date the person stopped taking or using the product: (b)(6) 2018. Reason for use: osteoarthritis; 3 injection(s), frequency: once wk for 3 wks, topical.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEUFLEXXA
Type of DeviceACID HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key7586500
MDR Text Key110734300
Report NumberMW5077725
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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

Patient Treatment Data
Date Received: 06/08/2018 Patient Sequence Number: 1
-
-