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

Catalog Number 6301182010

Device Problem Off-Label Use (1494)

Patient Problems Abdominal Pain (1685); Inflammation (1932); Pain (1994); Constipation (3274); Pancreatitis (4481); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Event Description

Pancreatic inflammation.Extreme pelvic pain.Inflammation.Abdominal pain.Severe constipation.Cramping.Low back pain.Consumer received euflexxa to right hip [product administered at inappropriate site].Consumer received euflexxa to right hip [off label] [off label use of device].Case narrative: case (b)(4) is a serious spontaneous case received from a nurse practitioner in the united states.This report concerns a 43 year old female who experienced pancreatic inflammation, extreme pelvic pain, inflammation, abdominal pain, severe constipation, low back pain, cramping, and the received euflexxa to the right hip [off label] during treatment with euflexxa (sodium hyaluronate) solution for injection unknown dose, route, and frequency, used for unknown indication from (b)(6) 2021 to an unknown stop date.A nurse practitioner reported that the patient received euflexxa treatment to her right hip on an unspecified date in (b)(6) 2021 and experienced extreme pelvic pain, inflammation, abdominal pain, pancreatic inflammation, severe constipation, low back pain and cramping, almost immediately since.The injection was given by a physician and the nurse practitioner wondered if the injection went into a blood vessel.The reporter stated that besides the pancreatic enzymes, the patient's unspecified lab values (date unspecified) were normal and did not show signs of sepsis.An ultrasound was done on an unspecified date and didn't show anything.The patient's insurance company would not approve magnetic resonance imaging (mri).A computerized tomography (ct) scan had been ordered for unspecified date.The patient was treated with an unspecified "cramping" medication.No further information provided.The pancreatic inflammation was medically significant.Action taken with euflexxa was unknown.At the time of reporting, the outcome of all the events was unknown.Concomitant medication and medical history were not reported.The event pancreatic inflammation was reported as serious.The events extreme pelvic pain, inflammation, abdominal pain, severe constipation, low back pain, cramping, and consumer received euflexxa to right hip, were reported as non-serious.Sender comment: despite of sodium hyaluronate's safety profile, a causal relationship between euflexxa's treatment and the event cannot be ruled out, however, based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the reported events.An important note is that euflexxa was administered off label.Company causality not related.Overall listedness (core label) is unlisted.Reporter causality: related; company causality: not related.Other case numbers: internal # - others: (b)(4).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.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 14078644
• MDR Text Key: 294521453
• Report Number: 3000164186-2022-00014
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 43 YR
• Patient Sex: Female