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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 Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Septic Shock (2068); Swelling (2091); Reaction, Injection Site (2442)
Event Date 12/01/2017
Event Type  Injury  
Event Description
Diagnosed with e. Coli [stomach upset, unable to eat] [escherichia infection]. Diagnosed with septic shock [septic shock]. Area was swollen [swelling]. Area was puffy [swelling]. Case (b)(4) is a serious, spontaneous case received from a consumer via a regulatory authority in united states. This report concerns a male of unknown age who experienced swelling and puffiness around the area, and was diagnosed with escherichia coli [stomach upset, unable to eat] and septic shock during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection (concentration and dose unknown), for an unknown indication from an unknown start date to an unknown stop date. It was reported that the patient was injected with euflexxa on (b)(6) 2017. It was reported that the patient saw his physician on the same day who noted the area was swollen and puffy (area was not defined). Five days later, at noon, the patient experienced an upset stomach and was unable to eat. In the evening, the patient's blood pressure was 77/50 with a pulse of 178. The patient was hospitalized on an unknown date for five days. The patient spent three days in the intensive care unit. It was reported that the patient was diagnosed with escherichia coli (e. Coli) and eventually septic shock. It was reported that the patient was feeling much better post discharge. The patient was hospitalized on an unknown date due to septic shock and escherichia coli [stomach upset, unable to eat]. Action taken with euflexxa was unknown. At the time of this report, the outcome of diagnosed with e. Coli [stomach upset, unable to eat] was recovering/resolving, the outcome of diagnosed with septic shock was recovering/resolving, the outcome of area was swollen was recovering/resolving, the outcome of area was puffy was recovering/resolving. Concomitant medication use and medical history were not reported. Relevant laboratory values included: blood pressure measurement: 77/50 ni (unknown), (b)(6) 2017. Heart rate: 178 ni (unknown), (b)(6) 2017. The events diagnosed with e. Coli [stomach upset, unable to eat], diagnosed with septic shock were reported as serious. The events area was swollen, area was puffy were reported as non-serious. At the time of reporting the case outcome was recovering/resolving. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: not related. Other case numbers: case number, others
=
mw5074646. Case numbers, complaint
=
(b)(4). This ae occurred in the u. S and concerns the medical device euflexxa. 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
kiryat malachi, 83104
IS 83104
Manufacturer (Section G)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
pob 571, be'er tuvia industria
kiryat malachi,, 83104
IS 83104
Manufacturer Contact
100 interpace parkway
parsippany, NJ 07054
9737961600
MDR Report Key7328418
MDR Text Key102070803
Report Number3000164186-2018-00005
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
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? No
Event Location No Information
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/09/2018 Patient Sequence Number: 1
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