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 Problem Congenital Defect/Deformity (1782)

Event Type  Injury  

Event Description

Foetal growth abnormality [foetal growth abnormality].Foetal growth restriction [foetal growth restriction].Foetal exposure during pregnancy [foetal exposure during pregnancy].Case (b)(4) is a serious spontaneous case received from a physician via health (b)(6) in (b)(6).This report concerns the foetus of a pregnant female who experienced foetal growth abnormality, foetal growth restriction and exposure during pregnancy during the mother's treatment with euflexxa (sodium hyaluronate)solution for injection unknown concentration, dose, route and frequency for an unknown indication from an unknown start date to an unknown stop date.The foetus experienced foetal growth abnormality, foetal growth restriction, and foetal exposure during pregnancy.Action taken with euflexxa was not applicable.Outcome: unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Sender¿s comment: very limited information regarding e.G.Patient's mother information and medical history was provided, it is difficult to perform a thorough medical evaluation, however, a causal relationship between mother's euflexxa treatment and the patient's event cannot be ruled out.Other case numbers: (b)(4).This ae occurred in (b)(6) 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.

Event Description

Foetal growth abnormality [foetal growth abnormality].Foetal growth restriction [foetal growth restriction].Foetal exposure during pregnancy [foetal exposure during pregnancy].Case (b)(4) is a serious spontaneous case received from a physician via (b)(6) canada in canada.This report concerns the foetus of a pregnant female who experienced foetal growth abnormality, foetal growth restriction and exposure during pregnancy during the mother's treatment with non-ferring sodium hyaluronate solution for injection unknown concentration, dose, route and frequency for an unknown indication from an unknown start date to an unknown stop date.The foetus experienced foetal growth abnormality, foetal growth restriction, and foetal exposure during pregnancy.The suspected medication was neovisc injection - not a ferring product.Action taken with sodium hyaluronate was not applicable.Outcome: unknown.Overall listedness (core label) unassessable.Reporter causality: related.Company causality: unassessable.Other case numbers: internal # - affiliate = 2020-ca-841.Internal # - others = ca2020-2517.Internal # - others = 000909256.*mw 3500a mfr.Rpt.# = 3000164186-2020-00020.This ae occurred in canada 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.Additional information received 01-feb-2022, from a physician, follow up 01: upon follow up, it was determined that the suspect medication was neovisc injection - not a ferring product.This ae occurred in canada and concerns non-ferring medical device 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; bee'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
• MDR Report Key: 11064270
• MDR Text Key: 228647828
• Report Number: 3000164186-2020-00020
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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 Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/18/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other