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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
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Underdose (2542)
Event Date 01/01/2019
Event Type  Injury  
Event Description
Strep b infection [beta haemolytic streptococcal infection] high sedimentation rate [red blood cell sedimentation rate increased] elevated white count [white blood cell count increased] did not have third injection [underdose] case (b)(6) is a serious spontaneous case received from physician's assistant (pa) via a sales rep in united states. This report concerns a (b)(6) -year-old female who experienced high sedimentation rate, strep b infection, elevated white count and did not have third injection during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown concentration and unknown dose, for unknown indication from an unknown start date and unknown if ongoing. The patient went to an orthopedic urgent care where they performed an aspiration on the patient and strep b were found in it. The patient had elevated white count. The patient also had a high sed rate and was advised to got to the hospital, where she may still be (sales rep was unsure as pa was reading from notes). The patient refused to have recommended procedure done. The pa requested a follow up call from medical director. The sales representative stated that patient did not have third injection of euflexxa and believed she had 2nd injection in (b)(6) 2019, although was unsure. Action taken with euflexxa was unknown. At the time of the report, the outcome of high sedimentation rate, strep b infection, elevated white count and did not have third injection were unknown. No concomitant medication was reported. The events high sedimentation rate, strep b infection, elevated white count were reported as serious. The event did not have third injection was 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. Other case numbers: (b)(6). 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 Key8731567
MDR Text Key149146801
Report Number3000164186-2019-00019
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 Physician Assistant
Type of Report Initial
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
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: 06/25/2019 Patient Sequence Number: 1
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