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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Underdose (2542)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Strep b infection [beta haemolytic streptococcal infection] high sedimentation rate [red blood cell sedimentation rate increased] elevated white count [white blood cell count increased] did not have third injection [underdose] case (b)(6) is a serious spontaneous case received from physician's assistant (pa) via a sales rep in united states.This report concerns a (b)(6) -year-old female who experienced high sedimentation rate, strep b infection, elevated white count and did not have third injection during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown concentration and unknown dose, for unknown indication from an unknown start date and unknown if ongoing.The patient went to an orthopedic urgent care where they performed an aspiration on the patient and strep b were found in it.The patient had elevated white count.The patient also had a high sed rate and was advised to got to the hospital, where she may still be (sales rep was unsure as pa was reading from notes).The patient refused to have recommended procedure done.The pa requested a follow up call from medical director.The sales representative stated that patient did not have third injection of euflexxa and believed she had 2nd injection in (b)(6) 2019, although was unsure.Action taken with euflexxa was unknown.At the time of the report, the outcome of high sedimentation rate, strep b infection, elevated white count and did not have third injection were unknown.No concomitant medication was reported.The events high sedimentation rate, strep b infection, elevated white count were reported as serious.The event did not have third injection was 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.Other case numbers: (b)(6).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.; 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: 8731567
• MDR Text Key: 149146801
• Report Number: 3000164186-2019-00019
• 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: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR