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 Fall (1848); Memory Loss/Impairment (1958); Weakness (2145); Arthralgia (2355); Blood Loss (2597)

Event Date 04/27/2018

Event Type  Injury  

Event Description

Falling/daughters found her on the floor [fall].Does not remember falling or what happened [memory impairment].Bleeding from injection site of right knee [injection site haemorrhage].Weak [asthenia].Drowsy [somnolence].Can no longer drive further described as lost her independence [loss of personal independence in daily activities].Had not had one pain free day since injections and pain is worse in knees than before [arthralgia].Case (b)(4) is a serious spontaneous case received from a consumer in united states.This report concerns a (b)(6) female who fell/daughters found her on the floor, does not remember falling or what happened, experienced bleeding from injection site of right knee, was weak, drowsy, can no longer drive further described as lost her independence and had not had one pain free day since injections and pain is worse in knees than before during treatment with euflexxa (sodium hyaluronate) solution for injection 2 ml, weekly, for osteoarthritis from (b)(6) 2018.The patient received her first injection of euflexxa in both knees on (b)(6) 2018 and the second injection was received on (b)(6) 2018.On (b)(6) 2018, the patient experienced bleeding from the injection site of the right knee and reported the blood ran down to her foot.The patient treated it with cold cloths and the bleeding stopped on (b)(6) 2018.On (b)(6) 2018 the patient's daughters found her on the floor and she was rushed to emergency room (er) by ambulance.The patient did not remember falling or what happened.This resulted in a five-day hospitalization.The patient was treated with steroids and did not remember what else happened during her hospitalization.The patient was discharged home with twenty-four-hour care, seven days a week, for three months.The patient reported she had not had one pain free day since she received the euflexxa injections and her pain was worse in her knees than before the injections.The patient also reported she can no longer drive, had lost her independence, was weak and drowsy.The patient did not have her third injection.No additional information was reported.The patient was hospitalized on (b)(6) 2018 due to falling/daughters found her on the floor and does not remember falling or what happened.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of had not had one pain free day since injections and pain is worse in knees than before was not recovered, the outcome of falling/daughters found her on the floor was recovered, the outcome of does not remember falling or what happened was not recovered, the outcome of can no longer drive further described as lost her independence was not recovered, the outcome of weak was not recovered, the outcome of drowsy was not recovered.On (b)(6) 2018, the outcome of bleeding from injection site of right knee was recovered.The patient`s medical history was significant for allergies to antibiotics (from unknown start date to unknown stop date) and allergic to fish (from unknown start date to unknown stop date) and drug hypersensitivity (from unknown start date to unknown stop date) and intestinal ischemia (from unknown start date to unknown stop date).Concomitant medication use was reported as unknown.The events falling/daughters found her on the floor, does not remember falling or what happened were reported as serious.The events bleeding from injection site of right knee, weak, drowsy, can no longer drive further described as lost her independence, had not had one pain free day since injections and pain is worse in knees than before were reported as non-serious.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.(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: 7917983
• MDR Text Key: 122005477
• Report Number: 3000164186-2018-00025
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• 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
• Date Manufacturer Received: 09/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 44