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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Loss of Range of Motion (2032); Arthralgia (2355)

Event Date 01/12/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Difficulty breathing [dyspnoea]; trouble raising arms above shoulders [joint range of motion decreased]; joint pain [arthralgia].This serious regulatory authority, spontaneous report was received from a consumer in united states, via the fda.This report concerns a patient of unknown age and gender who experienced difficulty breathing, trouble raising arms above shoulders, and joint pain during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, for an unknown indication on unknown dates.The patient reported that once they received the first of the three euflexxa injections (date of injection unknown) on (b)(6) 2015 they suffered difficulty breathing and extreme joint pain.They reported that five months later they were still having difficulty breathing and was experiencing trouble raising their arms above their shoulders.The patient reported the events were serious due to serious injury resulting in disability/permanent damage.Action taken with euflexxa was unknown.On an unknown date, the outcome of difficulty breathing was not recovered, the outcome of joint pain was unknown, the outcome of trouble raising arms above shoulders was not recovered.Concomitant medication use was not reported.At the time of reporting the case outcome was not recovered/ not resolved.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: mw5042925.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 5531278
• MDR Text Key: 41343139
• Report Number: 3000164186-2016-00005
• 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
• Report Date: 03/18/2016

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/16/2016
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability