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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 Problem Cancer (3262)
Event Date 06/25/2021
Event Type  Injury  
Event Description
Diagnosed with pancreas cancer [pancreatic carcinoma] case (b)(6) is a serious spontaneous case received from a health professional via a regulatory authority in united states. This report concerns a female patient of unknown age, who was diagnosed with pancreas cancer during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration, frequency and dose, for unknown indication from an unknown start date to an unknown stop date. Batch number not reported. The health professional reported that on (b)(6) 2021, the patient was diagnosed with pancreas cancer. The diagnosed with pancreas cancer was medically significant. Action taken with euflexxa was unknown. At the time of this report, the outcome of diagnosed with pancreas cancer was not recovered. Concomitant medication and medical history were not reported. All events in the case were reported as serious. At the time of reporting the case outcome was not recovered. Sender comment: important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, as well as therapy dates, preventing to establish a causal temporal relationship and preventing a proper medical assessment. Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's pancreas cancer. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: not related. Other case numbers: internal # - others
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mw5102210. This ae occurred in united states 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 does not meet the definition of a medical device incident according to the requirements of the medical device directive/ because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.
 
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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
9737961600
MDR Report Key12675082
MDR Text Key277884441
Report Number3000164186-2021-00044
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
Reporter Occupation
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
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 Received10/07/2021
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: 10/21/2021 Patient Sequence Number: 1
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