MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; 1% SODIUM HYALURONATE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Apnea (1720); Rheumatoid Arthritis (1724); Dyspnea (1816); Fever (1858); Unspecified Infection (1930); Lupus (1956); Rash (2033); Ulceration (2116); Arthralgia (2355); Depression (2361); Vascular System (Circulation), Impaired (2572)

Event Type  Injury  

Event Description

Cutaneous leukocytoclastic vasculitis (lcv) [hypersensitivity vasculitis] case (b)(4) is a serious spontaneous case, reported in a medical journal by a health professional in (b)(6).The report concerns a (b)(6) female who developed cutaneous leukocytoclastic vasculitis (lcv) during treatment with intra-articular sodium hyaluronate (sodium hyaluronate) solution for injection, for osteoarthritis.Dose and therapy dates were not provided.The patient, diagnosed with osteoarthritis of the knee received an intra-articular knee injection of hyaluronic acid (ha).This was her first ha injection.One week after the injection, the patient developed a rash over her lower extremities and abdomen.50 mg of prednisone was administered for three days, followed by a tapering regime, and referral to rheumatology was made.The patient was reviewed in the rheumatology clinic two weeks later.The rash was persistent.She had no history of sinus issues, cough, hemoptysis, dyspnea, fever or arthralgia.There was no history of a previous similar rash, recent infections or any new medications.Her past medical history was remarkable for tachyarrhythmia-induced cardiomyopathy treated with ablation, obstructive sleep apnea and depression.Her current medications included prednisone 5 mg daily, citalopram, lansoprazole, and acetaminophen with codeine.Her family history was significant for type i diabetes, lupus and rheumatoid arthritis.On examination, vital signs were stable and she was afebrile.Head and neck, chest and cardiovascular examinations were unremarkable.Knees demonstrated medial joint space tenderness without evidence of effusion.Cutaneous examination revealed palpable purpura predominantly over her lower extremities, with extension to the skin of her abdomen and forearms.Several areas of rash were confluent and beginning to ulcerate.Lab work up revealed normal cbc, cr, lfts, crp, esr and urinalysis.Anca (anti-neutrophil cytoplasmic antibodies) and ana (antinuclear antibodies) were negative.A chest x-ray was reported normal.A diagnosis of isolated cutaneous leukocytoclastic vasculitis (lcv) was suspected.Due to the widespread distribution of her rash and ulceration, she was prescribed 40 mg of prednisone daily with a slower tapering regimen.A skin punch biopsy confirmed lcv.The patient had difficulty tapering prednisone below 10 mg initially due to recurrence of new skin lesions.After five months, however, she was able to taper off prednisone completely.She has not had recurrence of vasculitis over the past 3 years.Similarly, that patient also developed vasculitis on both legs, abdomen and arms within one week of the injection.Action taken to sodium hyaluronate was not applicable.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).This ae occurred in canada and concerns the medical device sodium hyaluronate (reported as hyaluronic acid with unknown trade name).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.

• Brand Name: EUFLEXXA
• Type of Device: 1% 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 Key: 7797144
• MDR Text Key: 117698793
• Report Number: 3000164186-2018-00022
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR