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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problems Dysphasia (2195); Loss of consciousness (2418); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Speech Disorder (4415); Joint Laxity (4526)

Event Date 09/16/2021

Event Type  Injury  

Event Description

Became unconscious [loss of consciousness], horrible bowel movement [bowel movement irregularity], knees buckled [joint instability], shaky [tremor], very disoriented [disorientation], could not verbalize my thoughts [aphasia], er thought i was having a stroke [cerebrovascular accident].Case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in united states.This report concerns a female of unknown age who became unconscious, horrible bowel movement, knees buckled, shaky, very disoriented and could not verbalize my thoughts/the emergency room thought she was having a stroke, during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration, used for unknown indication from an unknown start date to an unknown stop date.The patient reported that on (b)(6) 2021, about three hours after receiving euflexxa injection into the right knee, she had a "horrible bowel movement", knees buckled, and she had to sit down as she was very shaky.The patient's friend suggested taking her blood pressure, but she was too shaky to do so.The friend took the patient to the emergency room where she stayed overnight.The patient was very disoriented, could not verbalize her thoughts and stated the emergency room thought she was having a stroke.The patient became unconscious.The patient had called the orthopedic office and told them about how she was feeling after the injection.They had told her to call the next day ((b)(6) 2021) if she did not feel better.Since she ended up in the emergency room, she was not able to call them.The emergency doctor called the patient's doctor.No further information was reported.The patient was hospitalized on (b)(6) 2021 due to became unconscious.The patient was hospitalized on (b)(6) 2021 due to horrible bowel movement.The patient was hospitalized on (b)(6) 2021 due to knees buckled.The patient was hospitalized on (b)(6) 2021 due to shaky.The patient was hospitalized on (b)(6) 2021 due to very disoriented.The patient was hospitalized on (b)(6) 2021 due to could not verbalize my thoughts.The patient was hospitalized on (b)(6) 2021 due to emergency room thought she was having a stroke.Action taken with euflexxa was unknown.At the time of the report, the outcome of became unconscious was unknown, the outcome of horrible bowel movement was unknown, the outcome of knees buckled was unknown, the outcome of shaky was unknown, the outcome of very disoriented was unknown, the outcome of could not verbalize my thoughts was unknown, the outcome of emergency room thought she was having a stroke was unknown.The following concomitant medications were reported: zinc (from an unknown start date to an unknown stop date), probiotics nos (from an unknown start date to an unknown stop date), ester-c [ascorbic acid] (from an unknown start date to an unknown stop date), vitamin k 2 (from an unknown start date to an unknown stop date), fish oil (from an unknown start date to an unknown stop date).All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, product indication, preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the reported events became unconscious, horrible bowel movement, knees buckled, shaky, very disoriented and could not verbalize my thoughts.Company causality unrelated.Other case numbers: internal # - others = mw5104173.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.

Event Description

Became unconscious [loss of consciousness].Horrible bowel movement [bowel movement irregularity].Knees buckled [joint instability].Shaky [tremor].Very disoriented [disorientation].Could not verbalize my thoughts [aphasia].Case 2021fe06428 is a serious spontaneous case received from a consumer via a regulatory authority in united states.This report concerns a female of unknown age who became unconscious, horrible bowel movement, knees buckled, shaky, very disoriented and could not verbalize my thoughts, during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration, used for unknown indication from an unknown start date to an unknown stop date.The patient reported that on (b)(6) 2021, about three hours after receiving euflexxa injection into the right knee, she had a "horrible bowel movement", knees buckled, and she had to sit down as she was very shaky.The patient's friend suggested taking her blood pressure, but she was too shaky to do so.The friend took the patient to the emergency room where she stayed overnight.The patient was very disoriented, could not verbalize her thoughts and stated the emergency room thought she was having a stroke.The patient became unconscious.The patient had called the orthopedic office and told them about how she was feeling after the injection.They had told her to call the next day (b)(6) 2021) if she did not feel better.Since she ended up in the emergency room, she was not able to call them.The emergency doctor called the patient's doctor.No further information was reported.The patient was hospitalized on (b)(6) 2021 due to became unconscious.The patient was hospitalized on (b)(6) 2021 due to horrible bowel movement.The patient was hospitalized on (b)(6) 2021 due to knees buckled.The patient was hospitalized on (b)(6) 2021 due to shaky.The patient was hospitalized on (b)(6) 2021 due to very disoriented.The patient was hospitalized on (b)(6) 2021 due to could not verbalize my thoughts.Action taken with euflexxa was unknown.At the time of the report, the outcome of became unconscious was unknown, the outcome of horrible bowel movement was unknown, the outcome of knees buckled was unknown, the outcome of shaky was unknown, the outcome of very disoriented was unknown, the outcome of could not verbalize my thoughts was unknown.The following concomitant medications were reported: zinc (from an unknown start date to an unknown stop date), probiotics nos (from an unknown start date to an unknown stop date), ester-c [ascorbic acid] (from an unknown start date to an unknown stop date), vitamin k 2 (from an unknown start date to an unknown stop date), fish oil (from an unknown start date to an unknown stop date).All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, product indication, preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the reported events became unconscious, horrible bowel movement, knees buckled, shaky, very disoriented and could not verbalize my thoughts.Company causality unrelated.Other case numbers: internal # - others = mw5104173.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.Amendment: (b)(6) 2021: event of stroke was removed from events per safety reviewer comments and from narrative as this was considered only the patient's perception and did not actually occur.Event was not originally removed prior to sending case to distribution.

• 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
• MDR Report Key: 12616413
• MDR Text Key: 276105615
• Report Number: 3000164186-2021-00043
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

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: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/21/2021
• Patient Sequence Number: 1
• Treatment: ESTER-C (ASCORBIC ACID); ESTER-C (ASCORBIC ACID); FISH OIL; FISH OIL; PROBIOTICS NOS (PROBIOTICS NOS); PROBIOTICS NOS (PROBIOTICS NOS); VITAMIN K 2 (MENAQUINONE-7); VITAMIN K 2 (MENAQUINONE-7); ZINC (ZINC); ZINC (ZINC)
• Patient Outcome(s): Hospitalization