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

Catalog Number 6301182010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Event Description

Blood pressure issues [blood pressure abnormal].Pain in right knee [arthralgia].Case narrative: case (b)(4) is a serious spontaneous case received from a non-health professional via regulatory authority in united states.This report concerns a 67-year-old male who experienced blood pressure issues during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration 2 ml, weekly for 3 weeks, for osteoarthritis from (b)(6) 2020.The patient reported being taken by ambulance to the hospital due to blood pressure issues.The patient experienced catheterization and had a stress test performed as well.Alliancerx walgreens prime (arxwp) had not filled this medication recently.On 12-may-2020, the physician provided lot number p17253a and expiration date of 08-sep-2021 for the three injections the patient received on (b)(6) 2020, (b)(6) 2020 and (b)(6) 2020.The patient's past examination records were provided and it was noted the patient experienced pain in right knee from an unknown date in 2017 to an unknown date in 2018 and had received euflexxa treatment previously in (b)(6) 2017(lot# m13811a; expiration date mar-2018), (b)(6) 2017 (lot# n10297a; expiration 27-oct-2018), oct-2018 (lot# n16424a; expiration date 21-aug-2019) and (b)(6) 2019 (lot# p14161a; expiration date 28-apr-2020) without difficulty.The patient was hospitalized due to blood pressure issues.Action taken with euflexxa was not applicable.At the time of this report, the outcome of blood pressure issues was unknown and pain in right knee was recovered.The patient's med hist/procedure was significant for caffeine use, arthritis, joint pain, allergy to iodine, hypertension, diabetes, gout, blood clots, physical therapy (from 02-feb-2018 to 06-apr-2018), left knee arthroplasty, non-smoker, obesity, chronic pain, x-ray skin dryness, itching, rashes and bronchitis.The patient's past drug therapy was significant for kenalon (from 17-nov-2016 to 15-oct-2017), lidocaine, synvisc and cortisone.The following concomitant medication was reported: furosemide, losartan, januvia, metformin, amlodipine, indomethacin and lantus.The event blood pressure issues was reported as serious.The event pain in right knee was reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related to "pain in right knee" and not related to "blood pressure issues." other case numbers: internal # others: mw5093675.Mw 3500a mfr.Rpt.#: 3000164186-2020-00007.E2b company number: (b)(4).This ae occurred in the us 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 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.Ferring's sender comment: association of euflexxa to the reported event "blood pressure issues" is confounded by the fact that the patients medical history contains "hypertension" and the concomitant medication indicates blood pressure depressing agents hence company causality is changed to not related to euflexxa.Additional information was received on 12-may-2020 from the physician, who did not deny or confirm the event occurrence: follow up 01: non serious event of pain in knee was reported, patient's date of birth, age, height, weight and medical history were provided.Euflexxa start/stop dates, indication, action taken was updated additional lot number, expiration date and concomitant medications were provided.Case fields and narrative updated accordingly.

• 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: 16438917
• MDR Text Key: 310232065
• Report Number: 0002244564-2020-00007
• 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: 02/23/2023

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
• Treatment: AMLODIPINE (AMLODIPINE),; FUROSEMIDE (FUROSEMIDE),; INDOMETHACIN [INDOMETACIN SODIUM] (INDOMETACIN SOD; JANUVIA (SITAGLIPTIN PHOSPHATE),; LANTUS (INSULIN GLARGINE),; LOSARTAN (LOSARTAN),; METFORMIN (METFORMIN),
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Weight: 122 KG