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

Catalog Number 6301182010

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Could possibly have a blood clot thrombosis.Increased pain [pain].Swelling increased [joint swelling].Case narrative: case (b)(4) is a serious complaint, spontaneous case received from a consumer in united states.This report concerns a male patient of unknown age, who "could possibly have a blood clot", increased pain, and swelling increased during treatment with euflexxa (sodium hyaluronate) solution for injection unknown route and concentration, 3 injections, for osteoarthritis from an unknown start date to an unknown stop date.The patient reported that his physician recommended euflexxa injections after knee x-rays were done (unspecified date), which showed his knees to be "bone-on-bone." after the completion of the euflexxa injections (dates not provided), the patient stated that swelling increased, causing increased pain.The patient reported that his physician had "washed his hands of him" and recommended that he see another physician as the patient "could possibly have a blood clot." no further information was provided.The "could possibly have a blood clot" was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of "could possibly have a blood clot" was unknown, the outcome of increased pain was unknown, the outcome of swelling increased was unknown.The patient's med hist/procedure was significant for x-ray (from unknown start date to unknown stop date).No concomitant medication was reported.The event "could possibly have a blood clot" was reported as serious.The events increased pain, swelling increased were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the 'possible bloth clot' event, but might most likely be related to the injection administrational procedure.Overall listedness (core label) is unlisted.Reporter causality: related company causality: unrelated for the blood clot (thrombosis) 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: 16552103
• MDR Text Key: 311482277
• Report Number: 0002244564-2021-00037
• 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: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male