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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 Arthritis (1723); Bacterial Infection (1735)
Event Type  Injury  
Event Description
Septic knee arthritis of the right knee [arthritis bacterial]. Case (b)(4) is a serious spontaneous case reported in a medical journal by a health professionals in (b)(6). This report concerns an (b)(6)-year-old female who experienced septic knee arthritis of the right knee during treatment with sodium hyaluronate solution for injection. Route of administration, indication, dose and therapy dates were not reported. Medical history: the patient was allergic to sulphonamides and penicillin. As clinical background, the patient presented a chronic renal impairment of multifactorial origin, in haemodialysis, and a calciphylaxis with a chronic ulcer on the lower right member. Furthermore, the patient suffered arterial hypertension, diabetes mellitus type ii, asymptomatic hyperuricemia under treatment with alopurinol and gonarthrosis, the patient had greater pain (mechanical type) in the last 2 months which was why she had received an intra-articulation infiltration with hyaluronic acid one month ago (with limited improvement). The patient was admitted at hospital due to an erythema on the lower right member and pain in the knee with poor inflammatory signs, with suspected cellulite. No fever was detected at home. On exploration at the hospital, discrete increase of the local temperature of the right knee and analytical elevation of reactive protein c of 28. 34mg / dl was observed with a normal blood count. In knee x-ray, a severe decrease in joint space was observed (arthrosis grade iii-iv). Arthrocentesis was performed, obtaining 1ml of synovial fluid of macroscopically inflammatory appearance, observing microscopically abundant leukocytes and intracellular pyrophosphate crystals were observed. An urgent biochemical test was not performed due to the scarcity of synovial fluid sample. Waiting for microbiological cultures and the possibility of septic origin of the arthritis (she is an immunosuppressed patient), empiric antibiotherapy was initiated. In a parallel way, in the culture of the synovial fluid p. Stutzeri , sensitive to meropenem and quinolones, and piperacillin resistant was isolated, being the synovial fluid and blood culture staining negative. The patient had remained thermodynamically stable throughout the hospitalization and she had favourably evolved with the antibiotic treatment: 2 weeks of meropenem, 1 g daily intravenous and subsequently 4 weeks of ciprofloxacin 500mg every 12 hours orally, without requiring joint drainage. Another option in differential diagnosis is a pyrophosphate monoarthritis (presence of crystals in the microscope and chronic renal disease with possible associated hyperparathyroidism). However, given the good response to antibiotic therapy without the need for corticosteroids or nsaids, they support septic origin in this case. Discussion: p. Stutzeri was usually found as saprophyte in soil, water and hospital environments and rarely lead to community-associated or serious nosocomial acquired infections. Cases of p. Stutzeri infection are usually immunocompromised patients with underlying diseases or previous surgery. It has been more frequently isolated in surgical wounds, blood, respiratory tract and urine. The case outcome was recovered. The case was serious due to medical significance. Overall listedness (core label) is unlisted. Reporter causality: related company causality: related sender comment (ferring): this case is considered as `serious deterioration in state of health` due to the medical intervention with antibiotics. No product name, strength or dose is available, however, it could not be ruled out that the suspected product could be ferring sodium hyaluronate. In addition, no batch number is available for investigation. This report is therefore considered final. Sodium hyaluronate is a sterile solution, however, bacterial contamination associated with the injection procedure is a risk. It is considered more likely that the septic arthritis is related to the medical intervention (injection) and not related to sodium hyaluronate per se. However, company causality is considered related. This ae occurred in (b)(6) and concerns the medical device sodium hyaluronate. Please report to your local health authority if required by local law. No corrective action was done by the manufacturer or requested by regulators. Translation of the literature received 20-dec-2019 added medical history, lab values and updated the narrative.
 
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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
8443044828
MDR Report Key9557741
MDR Text Key189356998
Report Number3000164186-2019-00054
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P010029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
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 Received12/20/2019
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: 01/07/2020 Patient Sequence Number: 1
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