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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING EUFLEXXA ACID HYALURONIC INTRAARTICULAR

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FERRING EUFLEXXA ACID HYALURONIC INTRAARTICULAR Back to Search Results
Lot Number L17762A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Complaint, Ill-Defined (2331)
Event Date 01/01/2016
Event Type  Injury  
Event Description
Pt stated no reaction or adverse effect to euflexxa. However, while updating medical history pt reported that she had a recent surgery for something found in her colonoscopy. The surgery found a tumor that will be checked again later this year and may need to be treated with oral chemo. While in the hospital they found a heart murmor. Dose or amount: 10mg, frequency: utd, route: sc. Dates of use: (b)(6) 2013 - ongoing.
 
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Brand NameEUFLEXXA
Type of DeviceACID HYALURONIC INTRAARTICULAR
Manufacturer (Section D)
FERRING
MDR Report Key6562782
MDR Text Key75143506
Report NumberMW5069710
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberL17762A
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

Patient Treatment Data
Date Received: 05/11/2017 Patient Sequence Number: 1
Treatment
CRESTOR ; ESTRADIOL; NEXIUM ; OMEGA3; VALTREX; VITAMIN C; WELCHOL
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