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 Diarrhea (1811); Nausea (1970); Concussion (2192); Urinary Frequency (2275); Malaise (2359); Loss of consciousness (2418)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Passed out [loss of consciousness], had a concussion [concussion], began to urinate more often than usual (every 20 minutes) [pollakiuria], vomiting [vomiting], nausea [nausea], diarrhea [diarrhoea], feeling sick [malaise].This serious spontaneous report was received from a consumer in united states.This report concerns a (b)(6) female who passed out, experienced a concussion, began to urinate more often than usual (every 20 minutes), vomiting, nausea, diarrhea, and feeling sick during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unk, weekly, for osteoarthritis from (b)(6) 2017 to an unknown stop date.The patient stated that she received one euflexxa shot in both knees on (b)(6) 2017.The morning after the shot ((b)(6) 2017), she began to urinate more often than usual (every 20 minutes) and later, in the middle of the night, on (b)(6) 2017, she began to experience nausea, vomiting, diarrhea, and feeling sick.When the patient tried to walk to the couch, she passed out and experienced a concussion.She went to the emergency room (er) on (b)(6) 2017.The experienced a concussion was medically significant.The passed out was medically significant.Action taken with euflexxa was unknown.On an unknown date, the outcome of passed out and experienced a concussion was unknown.In 2017, the outcome of began to urinate more often than usual (every 20 minutes), vomiting, nausea, diarrhea, and feeling sick was recovered.The following concomitant medications were reported: meloxicam (from an unknown start date to an unknown stop date), simvastatin (from an unknown start date to an unknown stop date), gabapentin (from an unknown start date to an unknown stop date).At the time of reporting, the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case 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.(b)(4).

Event Description

Passed out [loss of consciousness], had a concussion [concussion], began to urinate more often than usual (every 20 minutes) [pollakiuria], vomiting [vomiting], hit my head [head injury], low blood pressure [hypotension], pressure in right knee [limb discomfort], nausea [nausea], diarrhea [diarrhoea], feeling sick [malaise], pain in right knee [arthralgia], this serious, spontaneous report was received from a consumer in united states.This report concerns a 58 year-old female who passed out, hit her head, got a concussion, fainted, began to urinate more often than usual (every 20 minutes), experienced vomiting, low blood pressure, pressure in right knee, nausea, diarrhea, feeling sick, and pain in right knee during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unk, weekly, for osteoarthritis from (b)(6) 2017 to an unknown stop date.The reporter stated that it was her first time getting a euflexxa injection.The patient received an injection in both knees on (b)(6) 2017.The patient experienced some pain and pressure in the right knee but not in the other knee.They felt okay after walking and followed instructions of not lifting any weight, taking it easy, walking, and did not stand for more than one hour.At 8 or 9 at night, the patient started urinating every 20 minutes until 3:00 am.She noted that she did not have diabetes and was drinking water throughout the night to replenish.In the middle of the night, on (b)(6) 2017, she began to experience nausea, vomiting, diarrhea, and feeling sick.She felt so sick and tried to get up to go to the couch to lay down and fainted and passed out due to low blood pressure.The patient hit her head and got a concussion.She went to the emergency room (er) on (b)(6) 2017 and received stitches behind her ear.The events of concussion, passed out, and fainted were medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of passed out, got a concussion, fainted, hit her head, low blood pressure, pressure in right knee, and pain in right knee was unknown.In 2017, the outcome of began to urinate more often than usual (every 20 minutes), vomiting, nausea, diarrhea, and feeling sick was recovered.The following concomitant medications were reported: meloxicam (from an unknown start date to an unknown stop date), simvastatin (from an unknown start date to an unknown stop date), gabapentin (from an unknown start date to an unknown stop date).At the time of reporting, the case outcome was unknown.Additional information was received from the consumer on 25-jul-2017 via regulatory authority: follow up 01- additional events of head injury, hypotension, limb discomfort, and arthralgia added to case.Narrative updated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case number, others = (b)(4), mw5070463.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.Argus number: (b)(4).

• 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: 6677750
• MDR Text Key: 78720786
• Report Number: 3000164186-2017-00014
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• 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
• Date Manufacturer Received: 07/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GABAPENTIN; GABAPENTIN (GABAPENTIN); MELOXICAM; MELOXICAM (MELOXICAM); SIMVASTATIN; SIMVASTATIN (SIMVASTATIN); GABAPENTIN (GABAPENTIN); MELOXICAM (MELOXICAM); SIMVASTATIN (SIMVASTATIN)
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 75