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U.S. Department of Health and Human Services

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

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BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. / FERRING PHARMACEUTICALS, INC. EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number R13626A
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/04/2020
Event Type  Injury  
Event Description
Progressive debilitating left knee swelling, pain, and persistent effusion; right mtp pain beginning 1 week after injection with euflexa. Euflexa injections on (b)(6) 2020. Multiple joint aspirations, synovial biopsy all negative cultures (bacterial, fungal, mycobacterial), negative broad range pcr testing.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. / FERRING PHARMACEUTICALS, INC.
MDR Report Key11453220
MDR Text Key239166405
Report NumberMW5099881
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
Type of Report Initial
Report Date 03/08/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberR13626A
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: 03/09/2021 Patient Sequence Number: 1
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