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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 Pain (1994); Ambulation Difficulties (2544)
Event Date 05/12/2021
Event Type  Injury  
Event Description
Hip surgery [hip surgery]. In a lot of pain [pain]. His knee hurts [arthralgia]. Knee pain causes him to limp when he tries to walk more than 3/4 of a mile [gait disturbance]. Case (b)(6) is a serious spontaneous case received from a non health professional via a regulatory authority in united states. This report concerns a male of unknown age who had hip surgery, in a lot of pain, his knee hurts and knee pain causes him to limp when he tries to walk more than 3/4 of a mile during treatment with euflexxa (sodium hyaluronate) solution for injection intra-articular, unknown concentration, dose and indication, from an unknown start date to an unknown stop date. The patient reported that he was in the hospital to have hip surgery on (b)(6) 2021 and that he was in a lot of pain, particularly his knee hurt, causing him to limp if he tried to walk more than three-quarters of a mile, even though he needed to gain strength and recover in his hips. The patient was hospitalized (b)(6) 2021 due to hip surgery. Action taken with euflexxa was unknown. At the time of reporting, the outcome of hip surgery, in a lot of pain, his knee hurts and knee pain causes him to limp when he tries to walk more than 3/4 of a mile was unknown. No concomitant medication was reported. The event hip surgery was reported as serious. The events in a lot of pain, his knee hurts and knee pain causes him to limp when he tries to walk more than 3/4 of a mile were reported as non-serious. At the time of reporting the case outcome was unknown. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related: athralgia, gait disturbance. Not related: hip surgery, pain. Ferring sender comment: the reason for the hip surgery is unknown, however, based on the known safety profile of sodium hyaluronate the surgery is considered not related to sodium hyaluronate. The pain is more likely considered related to the surgery and not related to sodium hyaluronate. Other case numbers: internal #: others: mw5102526. 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 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
9737961600
MDR Report Key12353601
MDR Text Key267835880
Report Number3000164186-2021-00032
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 other
Reporter Occupation
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
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 Received08/03/2021
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: 08/23/2021 Patient Sequence Number: 1
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