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 Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Anaphylactoid (2218); Loss of consciousness (2418); Sweating (2444); Diminished Pulse Pressure (2606)

Event Date 01/01/2016

Event Type  Injury  

Event Description

Anaphylactic reaction [anaphylactic reaction].Low pulse [heart rate decreased].No blood pressure [blood pressure abnormal].Sweaty [hyperhidrosis].Lightheaded [dizziness].Passed out [loss of consciousness].Case (b)(4) is a serious spontaneous case received from a consumer in united states.This report concerns an elderly male patient who experienced anaphylactic reaction, sweaty, light headed, dizzy, passed out and low pulse and no blood pressure during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for an unknown indication from 2016 to an unknown stop date.The patient reported "anaphylactic" reaction to euflexxa approximately five years ago (2016).The patient stated reaction began 30 seconds to a minute after receiving the injection.He became sweaty, light headed, dizzy, and passed out.The patient stated that he had "no blood pressure" and a low pulse was put in a chair, and stated that he felt the doctor hit him hard in the chest or shoulder and yelled his name, then he woke up.The patient stated that he was taken over to the hospital across the street and could not recall if he was released the same day or the next day.The patient also reported having a right knee replacement for being "bone on bone" after this incident unspecified date.The patient was hospitalized on an unknown date due to anaphylactic reaction, sweaty, light headed, dizzy, passed out, low pulse and no blood pressure.Action taken with euflexxa was unknown.In 2016, the outcome of anaphylactic reaction, sweaty, light headed, dizzy, passed out, low pulse and no blood pressure was recovered.The patient's med hist/procedure was significant for right knee replacement (from unknown start date to unknown stop date).No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related for event 'anaphylactic reaction' and not related for events of 'sweaty', 'light headed', 'dizzy', 'passed out', 'low pulse' and 'no blood pressure'.Other case numbers: internal # - others = (b)(4).Sender comment: as very limited information regarding e.G.Medical history, concomitant medication was available, it is difficult to perform a thorough medical evaluation.Even though there is a possible temporal relationship between the reported events and euflexxa, typical signs or symptoms of an anaphylactic reaction such as cutaneous or respiratory were not reported but light-headedness, dizziness and sweat which matches more with a vasovagal syncope (probably caused by the injection procedure itself rather than the product) which maybe have been perceived by this patient as an "anaphylactic reaction".Therefore, these ones have been assessed as not related to euflexxa.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; bee'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
• MDR Report Key: 11217221
• MDR Text Key: 258416134
• Report Number: 3000164186-2021-00003
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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: 01/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 93