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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthralgia (2355); Ambulation Difficulties (2544); Balance Problems (4401); Swelling/ Edema (4577)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Walking funny and need for use of a cane [gait disturbance].Feeling wobbly [balance disorder].Knee pain [arthralgia].Knee swelling [joint swelling].Case narrative: case (b)(4) is a serious complaint spontaneous case received from a consumer in united states.This report concerns a 69-year-old female whose walking was funny and need for use of a cane, feeling wobbly, knee pain and knee swelling during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route weekly for 3 weeks, for an unknown indication from (b)(6) 2021.The patient received a three injection series of euflexxa, between (b)(6) 2021, with her second shot on (b)(6) 2021.On an unspecified date, beginning after her first injection of euflexxa, the patient experienced bilateral knee pain, swelling, feeling wobbly, walking funny and need for use of a cane, which she did not typically use.As treatment, she used ice on her knees.The patient further noted that the unspecified pain medication she had been prescribed for her spinal stenosis, helped to take the edge off of her knee pain.No further information provided the walking funny and need for use of a cane was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of walking funny and need for use of a cane was not recovered, the outcome of feeling wobbly was not recovered, the outcome of knee pain was not recovered, the outcome of knee swelling was not recovered.The patient's med hist/procedure was significant for spinal stenosis (from unknown start date to unknown stop date) and need use of a cane (from (b)(6) 2021 to unknown stop date).The concomitant medication included unspecified pain medication for history of spinal stenosis.The event walking funny and need for use of a cane was reported as serious.The events feeling wobbly, knee pain, knee swelling 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: related.Other case numbers: internal #: others: (b)(4); internal #: affiliate: (b)(4); internal #: complaint: (b)(4).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.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• MDR Report Key: 16438960
• MDR Text Key: 310234212
• Report Number: 0002244564-2021-00028
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

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: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female