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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 1% SODIUM HYALURONATE

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BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 1% SODIUM HYALURONATE Back to Search Results
Catalog Number 6301182010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bacterial Infection (1735)
Event Type  Injury  
Event Description
Septic arthritis of the knee [arthritis bacterial]. Case (b)(4) is a serious spontaneous case from a medical journal by a physician in united states. This case concerns a (b)(6)-year-old male who experienced septic arthritis of the knee on an unknown date during treatment with intra-articular sodium hyaluronate (sodium hyaluronate) solution for injection for osteoarthritis. The concentration of the product, dosing regimen, treatment period and batch no. Was unknown. The septic arthritis of the knee was medically significant. The patient had a medical history significant for ankylosing spondylitis, (b)(6), non-ischemic cardiomyopathy, chronic left bundle branch block, depression, hypogonadism, as well as multifocal (b)(6) joint infections (left elbow, left wrist, right shoulder, and lumbar spine) resulting in multiple hospitalizations for sepsis. He also had a history of left acl reconstruction. He was experiencing significant pain from end-stage left knee arthritis. The patient was recommended continued conservative management. The patient later had an intra-articular injection with sodium hyaluronate by his primary care physician which was complicated by septic arthritis of the knee. Action taken to sodium hyaluronate was unknown. No concomitant medication was reported. At the time of reporting the case outcome was unknown. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: not related. Sender comment (ferring): company causality is considered not related to sodium hyaluronate due to the fact that this is an immunosuppressed patient with several comorbidities and endstage knee arthritis. This ae occurred in united states and concerns the medical device sodium hyaluronate. Please report to your local health authority if required by local law. This ae is not reportable in eu because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer. No corrective action was done by the manufacturer or requested by regulators.
 
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Brand NameEUFLEXXA
Type of Device1% SODIUM HYALURONATE
Manufacturer (Section D)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
be'er tuvia industrial zone
pob 571
kiryat malachi, 83104
IS 83104
Manufacturer (Section G)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
be'er tuvia industrial zone
pob 571
kiryat malachi, 83104
IS 83104
Manufacturer Contact
100 interpace parkway
parsippany, NJ 07054
8443044828
MDR Report Key9597604
MDR Text Key189831368
Report Number3000164186-2020-00002
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number6301182010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/16/2020 Patient Sequence Number: 1
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