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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cellulitis (1768); Edema (1820); Itching Sensation (1943); Pain (1994); Ambulation Difficulties (2544); Fluid Discharge (2686)

Event Date 12/12/2018

Event Type  Injury  

Event Description

Diagnosed with cellulitis of right leg (signs/symptoms of the definitive diagnosis);(cellulitis); hyperglycemia; groin pains; welling up to thigh, bilateral edema (oedema periphera).Case (b)(4) is a serious spontaneous case received from a consumer in united states.This report concerns a (b)(6) year-old male who was diagnosed with cellulitis of right leg (signs/symptoms of the definitive diagnosis), hyperglycemia, groin pain and bilateral edema during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, route and dose, for osteoarthritis from (b)(6).On (b)(6) 2018, the patient received his first injection of euflexxa in both knees.On (b)(6) 2018, the patient experienced severe pain in legs, swelling up to thigh, itching, leg was blood red, scratching which caused it to bleed, bumps on leg from the knee down and bumps leaking fluid.The patient could hardly walk and needed to walk with a walker.On an unspecified case in (b)(6) 2018 the patient also reported experiencing groin pain.On (b)(6) 2018, the patient went to the doctor and was diagnosed with cellulitis of right leg, bilateral edema and hyperglycemia and was given a cortisone injection and was prescribed vibramycin, prednisone, and clindamycin.The patient also had a bilateral leg ultrasound which showed normal arteries and veins.At the time of this report, the patient was going for edema therapy and was wearing stockings.Reportedly the edema goes down at night after wearing the stockings but reappears after getting up.No additional information was provided.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of diagnosed with cellulitis of right leg (signs/symptoms of the definitive diagnosis), bilateral edema, and hyperglycemia were not recovered.The outcome of groin pain was unknown.Concomitant medication reported: unknown diabetes medication (injection).Medical history included drug allergy and caffeine allergy.Relevant laboratory values included: ultrasound scan: normal arteries and veins ni (normal), (b)(6) 2018.The event diagnosed with cellulitis of right leg [signs/symptoms of the definitive diagnosis], was reported as serious.The events hyperglycemia, groin pain, and bilateral edema were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = (b)(4).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.

• 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: 8322604
• MDR Text Key: 135768050
• Report Number: 3000164186-2019-00006
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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: 01/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 86