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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 07/27/2019

Event Type  Injury  

Event Description

Face began to swell [swelling face] case (b)6) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a female (age unknown) who experienced face began to swell during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for an unknown indication from an unknown start date to an unknown stop date.On an unspecified date, the patient had euflexxa injected in both knees and on (b)(6) 2019 (within days of the injections), the patient's face began to swell.The patient was examined at urgent care and was given a medication to counteract the reaction.Action taken with euflexxa was unknown.No concomitant medication was reported.Event of 'swelling face' was reported as serious.At the reporting time, the outcome for event of 'swelling face' was unknown.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = mw5088451 this ae occurred in united states and concerns the medical device 1% sodium hyaluronate.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.; 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: 9086636
• MDR Text Key: 163013752
• Report Number: 3000164186-2019-00036
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other