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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Myalgia (2238); Ambulation Difficulties (2544)

Event Date 08/05/2019

Event Type  Injury  

Event Description

Could not put any weight on the affected limb and had to go to the hospital [weight bearing difficulty].Notable calf pain [pain in extremity].Lower extremity pain [pain in extremity].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a female who could not put any weight on the affected limb and had to go to the hospital and notable calf pain and lower extremity pain during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unknown dose, for an unknown indication from an unknown start date to an unknown stop date.The patient had a serious adverse reaction to the second and third injections of the medication.The patient reported that the second injection cause notable calf and lower extremity pain and within a week of the third injection she could not put any weight on the affected limb and had to go to the hospital, with the debilitation persisting to this day.The events of weight on the affected limb and had to go to the hospital, notable calf pain and lower extremity pain are medically significant.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of notable calf pain and lower extremity pain and could not put any weight on the affected limb and had to go to the hospital was not recovered.No concomitant medication was reported.All events in the case were reported as 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: internal # - others = mw5090100.This ae occurred in united stated 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: 16438994
• MDR Text Key: 310201184
• Report Number: 0002244564-2019-00048
• 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: 02/22/2023

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): Required Intervention; Other
• Patient Sex: Female