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); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Skin Inflammation (2443)

Event Date 04/01/2018

Event Type  Injury  

Event Description

Pain throughout his body [pain]; puffy [swelling]; swelled up [swelling]; joint pain throughout his body [arthralgia]; severe redness of his right knee and throughout entire body [erythema]; pain of his right knee [arthralgia]; ankle pain [arthralgia]; leg pain [pain in extremity]; elbow pain [arthralgia]; pain in knuckles [pain in extremity]; pain in shoulders [musculoskeletal pain]; pain in arms [pain in extremity].Case description: case (b)(4) is a serious, spontaneous case received from a consumer in united states.This report concerns (b)(6)-year-old male who experienced pain throughout his body, was puffy, swelled up, had joint pain throughout his body, experienced severe redness of his right knee and throughout the body and pain in his right knee, ankle, leg, elbow, knuckles, shoulders and arms during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, with unknown dosing regimen, for osteoarthritis from an unknown start date to (b)(6) 2018.It was reported that the patient started treatment with euflexxa for osteoarthritic pain in (b)(6) 2016.It was reported that euflexxa worked for the first two series of injections he received and experienced no adverse events.However, it was reported that after the consumer received his third injection of his third series of euflexxa on an unspecified date in (b)(6) 2018, the patient experienced severe redness and pain of his right knee with a pain of nine out of ten.The patient had pain throughout his body including the ankles, knees, legs, elbows, knuckles, shoulders, and arms.The patient also swelled up and was puffy.It was reported that the patient went to the emergency room (er) twice during the first weekend of (b)(6) 2018.It was reported that the patient was prescribed prednisone by his orthopedic physician for five days and it did not work.The patient had severe joint pain throughout his body which had escalated and was not improving.The events of pain throughout his body, swelled up, puffy and joint pain throughout his body were medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of pain throughout his body was not recovered, the outcome of puffy was not recovered, the outcome of swelled up was not recovered, the outcome of joint pain throughout his body was not recovered, the outcome of severe redness of his right knee was not recovered, the outcome of pain of his right knee was not recovered, the outcome of ankle pain was not recovered, the outcome of leg pain was not recovered, the outcome of elbow pain was not recovered, the outcome of pain in knuckles was not recovered, the outcome of pain in shoulders was not recovered, the outcome of pain in arms was not recovered.The patient`s medical history was significant for type 2 diabetes, heart disease and high blood pressure.Concomitant medication use was not reported.Relevant laboratory values included: pain assessment: 9, ni (elevated), (b)(6) 2018.The events pain throughout his body, puffy, swelled up, joint pain throughout his body were reported as serious.The events severe redness of his right knee, pain of his right knee, ankle pain, leg pain, elbow pain, pain in knuckles, pain in shoulders, pain in arms 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.Other case numbers: (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.

• 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: 7552823
• MDR Text Key: 109515253
• Report Number: 3000164186-2018-00017
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Weight: 95