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); Skin Discoloration (2074); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Injection Site Reaction (4562); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Possible blockage [thrombosis].Difficulty in ambulating [gait disturbance]."wood" like feeling in lower leg [sensory disturbance].Discoloration of foot [skin discolouration].Strained her ankle [ligament sprain].Edema [oedema peripheral].Intermittent excruciating pain [pain in extremity].Third injection was extremely painful [injection site pain].Case narrative: this is a serious complaint, spontaneous case received from a consumer in the united states.This report concerns an 81 year old female who experienced intermittent excruciating pain, edema, difficulty in ambulating, "wood" like feeling in lower leg, discoloration of foot and strained ankle during treatment with euflexxa (sodium hyaluronate) solution for injection unknown dose and route, 1 injection weekly for three weeks, for unknown indication from (b)(4) 2021 to (b)(4) 2021.On (b)(4) 2022, the patient reported that she received a three series injection of euflexxa beginning on (b)(4) 2021 and completed on (b)(4) 2021.Since the euflexxa injections, the consumer had a very difficult time with intermittent excruciating pain, edema, difficulty in ambulating, "wood" like feeling in the lower leg and discoloration of foot.The first two euflexxa injections were given by the "doctor's helper" and went well.The third euflexxa injection was given by the physician and the consumer said the injection was extremely painful and not like any others she has ever received.She had not returned to that office and refused to.The patient went to an unspecified emergency department on unspecified dates.They ruled out blood clots, and on one occasion told her she strained her ankle.It was wrapped in an ace bandage and she was sent home.She was seen by a new primary physician, on an unspecified date, and underwent a lot of unspecified "tests".On unspecified dates she was advised to take a "water pill", which only helped a bit.She saw a "vein surgeon" and got x-rays, two weeks ago, on an unspecified date.She was told nothing was wrong with her veins in either leg, but it was thought she could possibly have a "blockage" somewhere in the abdominal area, above the hip.In one week she will undergo a "pelvic venogram." on unspecified dates, prior to her use of euflexxa, the patient received a five series of supartz injections to the knee and had wonderful results with no side effects.No further information provided.Action taken with euflexxa was not applicable.The patient's med hist/procedure was significant for glaucoma (from unknown start date to unknown stop date) and torn meniscus (from 2009 to unknown stop date).The patient's past drug therapy was significant for supartz (from unknown start date to unknown stop date).No concomitant medication was reported.The event of possible blockage was reported as serious.The other events in the case were reported as non-serious.The event of possible blockage was medically significant.At the time of reporting the outcome of the events of intermittent excruciating pain, edema, difficulty in ambulating, "wood" like feeling in lower leg, discoloration of foot, ankle strain and third injection was extremely painful were unknown.Sender comment: based on the company´s safety profile for sodium hyaluronate it is considered unlikely to cause the event "blockage" in abdominal area, hence company causality is not related.Overall listedness (core label) is unlisted.Reporter causality: not reported.Company causality: related (intermittent excruciating pain, edema, difficulty in ambulating, "wood" like feeling in lower leg, and discoloration of foot, third injection was extremely painful) / not related (possible blockage and ankle strain).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.Correction 22-nov-2022: text updated in the narrative with no impact on overall case evaluation.'non-serious' amended to 'serious' only in the narrative (typographical error during de).

• 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: 16551707
• MDR Text Key: 311482604
• Report Number: 0002244564-2022-00037
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Female