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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 Problems Inflammation (1932); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Patient had second hip replacement (b)(6) 2021, diagnosed with crps, chronic regional pain syndrome, (b)(6) 2021 bladder and kidney inflammation after both covid vaccine (pfizer) first required hospitalization to relieve pressure and stones.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
MDR Report Key12737846
MDR Text Key279817214
Report NumberMW5105059
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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: 11/01/2021 Patient Sequence Number: 1
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