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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS, INC / BIO-TECHNOLOGY GENERAL (ISRAEL), LTD. EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR

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FERRING PHARMACEUTICALS, INC / BIO-TECHNOLOGY GENERAL (ISRAEL), LTD. EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Malaise (2359); Heart Failure/Congestive Heart Failure (4446)
Event Type  Death  
Event Description
Patient wife reported pt passed away on (b)(6) 2021. Medications discontinued - euflexxa, vemlidy, tacrolimus. She stated he was not feeling well, lots of complications, heart failure. No additional information provided. Reported to (b)(6) by pt/caregiver.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS, INC / BIO-TECHNOLOGY GENERAL (ISRAEL), LTD.
MDR Report Key12384285
MDR Text Key268905306
Report NumberMW5103547
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 08/27/2021 Patient Sequence Number: 1
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