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

Catalog Number 6301182010

Device Problems Patient-Device Incompatibility (2682); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544)

Event Date 05/18/2018

Event Type  Injury  

Event Description

Can't walk [gait inability].In misery [feeling abnormal].Constant pain [pain].Her knees grind continuously [arthropathy].It was a different company [product substitution issue].Case (b)(6) is a serious complaint, spontaneous case received from a consumer in united states.This report concerns a (b)(6) year old female who couldn't walk, was in misery, constant pain, her knees grind continuously, and it was a different company [product substitution issue] during treatment with euflexxa (sodium hyaluronate) solution for injection 20 mg, route of administration unknown, 20 mg, weekly for 3 weeks in both knees, for osteoarthritis from (b)(6) 2018.The patient received her second injection on (b)(6) 2018 and reported that the label on the syringe for second injection read bluflexxa.When she asked the physician why it said that he said it was a different company; however, she was being charged for euflexxa.After receiving the second injection, she was in misery, her knees grind continuously, she was in constant pain, and she couldn't walk.She received her third injection on (b)(6) 2018 and events continued.The patient reported that she had euflexxa injections in past with no issues.The patient was disabled or suffered permanent damage due to can't walk.Action taken with euflexxa was dose not changed.On an unknown date, the outcome of can't walk was not recovered, the outcome of in misery was not recovered, the outcome of constant pain was not recovered, the outcome of her knees grind continuously was not recovered, the outcome of it was a different company was unknown.The patient's medical history was significant for high blood pressure (from unknown start date to unknown stop date), obesity (from unknown start date to unknown stop date), and weight surgery (from unknown start date to unknown stop date).The patient's past drug history was significant for synvisc and synvisc one (bad swelling which became heated and felt like her leg was paralyzed.Treatment included being on a walker up to 10 days.) the following concomitant medication was reported: triamterene and hydrochlorothiazide (from an unknown start date to an unknown stop date), flexitine (from an unknown start date to an unknown stop date), potassium (from an unknown start date to an unknown stop date), calcitriol (from an unknown start date to an unknown stop date), losartan (from an unknown start date to an unknown stop date), and pravastatin (from an unknown start date to an unknown stop date).The event can't walk was reported as serious.The events in misery, constant pain, her knees grind continuously, it was a different company were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: case number, others = (b)(6).Case number, complaint = (b)(6).Case number, complaint = (b)(6).This ae occurred in 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 (b)(6) because it did not occur in a (b)(6) + (b)(6) 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: 7641003
• MDR Text Key: 112432340
• Report Number: 3000164186-2018-00019
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CALCITRIOL (CALCITRIOL); LOSARTAN (LOSARTAN); POTASSIUM (POTASSIUM); PRAVASTATIN; TRIAMTERENE AND HYDROCHLOROTHIAZID
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Weight: 139