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 Chest Pain (1776); Fall (1848); Fatigue (1849); Bone Fracture(s) (1870); Hemorrhage, Cerebral (1889); Pain (1994); Swelling (2091); Arthralgia (2355)

Event Date 02/20/2017

Event Type  Injury  

Event Description

Bleeding on brain [cerebral haemorrhage], chest pain [chest pain], severe fall in my apartment [fall], two cracked ribs [rib fracture], extreme pain [pain], swelling [swelling], shoulder pain [musculoskeletal pain], right knee extreme pain [arthralgia], very tired, slept three hours after third injection [fatigue].This serious, regulatory authority, spontaneous report was received from a consumer in united states.This report concerns a patient of unknown age and gender who experienced bleeding on brain, chest pain, severe fall in my apartment, two cracked ribs, extreme pain, swelling, shoulder pain, right knee extreme pain, and very tired, slept three hours after third injection during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration of unknown dose, 3 week period, for an unknown indication from 2017 to 2017.The patient reported bleeding on brain, right knee extreme pain, chest, shoulders.They reported they experienced a severe fall in their apartment at 5:20 am on an unspecified date in 2017.Two cracked ribs.They were hospitalized (date unspecified) and sent to rehab for three weeks.They reported extreme pain, swelling, and being very tired.They slept for three hours after the third injection of euflexxa.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of the events was unknown.Medical history was not reported.The following concomitant medication was reported: metoprolol, resveratrol, b12, vitamin c, vitamin d3.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, others = mw5070072.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).

• 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; 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737967600
• MDR Report Key: 6711126
• MDR Text Key: 79957746
• Report Number: 3000164186-2017-00019
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2017
• 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
• Treatment: B12; METOPROLOL; RESVERATROL; VITAMIN C; VITAMIN D3
• Patient Outcome(s): Hospitalization; Other