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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 Problems Hypersensitivity/Allergic reaction (1907); Respiratory Distress (2045)
Event Date 09/07/2017
Event Type  Injury  
Event Description
Began having a flare up of her hypersensitivity pneumonitis (described as respiratory issues and flushing) [alveolitis allergic]. (b)(4) is a serious, spontaneous case received from a consumer in united states. This report concerns a (b)(6) female who began having a flare up of her hypersensitivity pneumonitis (described as respiratory issues and flushing) during treatment with euflexxa (sodium hyaluronate) solution for injection (concentration, dose and route unknown), weekly, for arthritis (knee) from (b)(6) 2017 to an unknown stop date. It was reported that the patient received her first shot of euflexxa on (b)(6) 2017. At 2 am on (b)(6) 2017, she experienced a flare up of her hypersensitivity pneumonitis. The patient experienced respiratory issues and flushing where it felt like her body was heating when it was not. The patient reported that she suspected it could be from the source of euflexxa. The event of flare up of her hypersensitivity pneumonitis (described as respiratory issues and flushing) was medically significant. Action taken with euflexxa was unknown. At the time of this report, the outcome of began having a flare up of her hypersensitivity pneumonitis (described as respiratory issues and flushing) was not recovered. The patient`s medical history was significant for hypersensitivity pneumonitis (from unknown start date to unknown stop date). Concomitant medication use was reported as unspecified asthma and allergy medications. All events in the case were reported as serious. At the time of reporting the case outcome was not recovered. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: (b)(4). This ae occurred in the us 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. (b)(4).
 
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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 Key6875768
MDR Text Key86600536
Report Number3000164186-2017-00026
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P010029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2017
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: 09/19/2017 Patient Sequence Number: 1
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