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

Catalog Number 6301182010

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Discomfort (2330)

Event Date 02/13/2019

Event Type  Injury  

Event Description

Knee locked up in the shower and would not bend [joint lock], intractable vomiting [vomiting], stomach sensitive [abdominal discomfort], headache [headache], nausea [nausea].Case (b)(4) is a serious, spontaneous case received from a consumer via a regulatory authority in united states.This report concerns a patient (no patient identifiers provided) whose knee locked up in the shower and would not bend, experienced intractable vomiting, stomach sensitive, headache and nausea during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for osteoarthritis from (b)(6) 2019.The patient reported that after the first injection of euflexxa on (b)(6) 2019, the patient experienced a headache the first day, intractable vomiting began approximately 22 hours later and the patient was unable to keep food or fluids down for 60 hours.Nausea lasted six days total and stomach was still sensitive.The patient's knee locked up in the shower and would not bend.The patient declined any further injections.The patient reported that they have me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome) and have an overactive immune response and thought it possible that their body saw the euflexxa as in invader of some type.No additional information was provided.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of knee locked up in the shower and would not bend was unknown, the outcome of stomach sensitive was not recovered.The outcome of intractable vomiting, nausea and headache were recovered.The patient`s medical history was significant for me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome).The following concomitant medications were reported: synthroid, cytomel, prevacid, vitamin d3, vitamin b12, vitamin b1 and calcium.The event knee locked up in the shower and would not bend was reported as serious.The events intractable vomiting, stomach sensitive, headache, nausea 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: knee locked up; not related intractable vomiting, stomach sensitive, headache, nausea.Other case numbers: internal # - others = mw5084268.This ae occurred in the 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.; 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: 8479532
• MDR Text Key: 140819053
• Report Number: 3000164186-2019-00011
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• 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
• Date Manufacturer Received: 03/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CALCIUM (CALCIUM); CYTOMEL (LIOTHYRONINE SODIUM); PREVACID (LANSOPRAZOLE); SYNTHROID (LEVOTHYROXINE SODIUM); VITAMIN B1; VITAMIN B12; VITAMIN D3 (COLECALCIFEROL)
• Patient Outcome(s): Other