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

Catalog Number 6301182010

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Arthralgia (2355)

Event Type  Injury  

Event Description

Allergy towards euflexxa [device allergy].Experienced chronic pain [knee] after the second and third injections; trying to tame the acute pain and recurring pain with prednisone [arthralgia].Experienced swelling [knee] after the second and third injections [joint swelling].Case narrative: this is a serious spontaneous case received from a consumer, via regulatory agency, in the united states.This report concerns a patient (no patient identifiers reported) who experienced an allergy towards euflexxa, chronic pain [knee] after the second and third injections; tried to tame the acute pain and recurring pain with prednisone and swelling [knee] after the second and third injections during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, 3 injections to left knee, for an unknown indication from an unknown start date to an unknown stop date.The patient reported they received three separate euflexxa injections to the left knee for treatment.The patient experienced chronic pain and swelling after the second and third injections and reported on three separate occasions they had to have large amounts of fluid removed from their knee.After the biopsy report was reviewed, it was determined by the rheumatologist that the root cause was an allergy to euflexxa.The patient was trying to tame the acute pain and recurring pain with prednisone.The patient stated knowing this type of reaction to the medication can occur and how to treat it would be helpful as they were mistakenly diagnosed with gout.The allergy towards euflexxa was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of allergy towards euflexxa was unknown, the outcome of experienced chronic pain [knee] after the second and third injections; trying to tame the acute pain and recurring pain with prednisone was unknown, the outcome of experienced swelling [knee] after the second and third injections was unknown.The patient's med hist/procedure was significant for large amounts of fluids removed from knee (unknown dates) and biopsy (unknown dates).No concomitant medication was reported.The event allergy towards euflexxa was reported as serious.The events experienced chronic pain [knee] after the second and third injections; trying to tame the acute pain and recurring pain with prednisone, experienced swelling [knee] after the second and third injections were reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Health effect - clinical codes: 1907: hypersensitivity /allergic reaction.1994: pain.4577: swelling/edema.4849: joint effusion.Sender comment: an allergic reaction to device could potentially be induced by a microorganism contamination, however, the fact that the patient reacts to all injections given and not to a specific one/lot (lot nor batch numbers not provided for investigation), suggests, that the patient presents hypersensitivity to a component(s) of euflexxa.According to ifu, euflexxa is contraindicated to treat patients who have a known hypersensitivity to hyaluronan preparations.Very limited and important information has not been reported for this consumer case.Furthermore, it is unknown if this patient has been administered with repeated treatment cycles (established up to 1 year) which guarantees product safety.Other case numbers: internal # - others = mw5117907.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 mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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: 17119418
• MDR Text Key: 317152182
• Report Number: 3000164186-2023-00032
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2023

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: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other