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U.S. Department of Health and Human Services

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

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FERRING / 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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/25/2021
Event Type  Injury  
Event Description
Patient's wife (b)(6) reported patient was admitted for 5 days for fluid in lungs is on amoxicillin for treatment. Patient has not yet filled medication with (b)(6).
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
MDR Report Key12432570
MDR Text Key270305830
Report NumberMW5103726
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
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? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 09/03/2021 Patient Sequence Number: 1
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