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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 Patient-Device Incompatibility (2682)
Patient Problem Synovitis (2094)
Event Type  Injury  
Event Description
Synovitis [synovitis]. Synovitis led to other knee problems [arthropathy]. Reaction in both knees [adverse reaction]. Patient requesting an investigation [device issue]. Case (b)(4) is a serious spontaneous case received from a pharmacist in united states. This report concerns a (b)(6) female who experienced severe synovitis, which led to other knee problems and reaction in both knees during treatment with euflexxa (sodium hyaluronate) solution for injection unknown dose, route and concentration, used for unknown indication from an unknown start date to an unknown stop date. Lot number r13626a with expiry date 28-mar-2021. A pharmacist reported that a patient reported she had a reaction in both knees that led to severe synovitis which led to other knee problems (unspecified). Euflexxa was filled in (b)(6) 2020, however, dates of injection(s) were unknown. The patient requested an investigation. The synovitis (severe) was medically significant. Action taken with euflexxa was unknown. At the time of the report, the outcome of severe synovitis was not recovered, the outcome of synovitis led to other knee problems was not recovered, the outcome of reaction in both knees was not recovered. No concomitant medication was reported. The event severe synovitis was reported as serious. The events synovitis led to other knee problems, reaction in both knees 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: synovitis, synovitis which led to other knee problems and reaction in both knees: not related. Patient requesting an investigation: related per convention. Sender comment: important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, therapy dates, onset dates, product indication etc. Preventing a proper medical assessment. Synovitis may occur in association with arthritis and other conditions although it is also present in many joints affected with osteoarthritis. Due to clinical interpretation in alignment with known safety profile, company causality for the synovitis and the other knee problems is considered not related to euflexxa. Other case numbers: internal # others
=
(b)(4). 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. 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 Key13015147
MDR Text Key288475310
Report Number3000164186-2021-00056
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 Pharmacist
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date03/28/2021
Device Catalogue Number6301182010
Device Lot NumberR13626A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
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