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 Hemorrhage/Bleeding (1888); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Breast/nipple bleeding since then [breast haemorrhage].Localized swelling [swelling].Pain to knee [arthralgia].Case narrative: this serious spontaneous case received from a consumer in united states.This report concerns a 70-year-old female who experienced breast/nipple bleeding, localized swelling, and pain to the knee during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown route, concentration, and dose, for an unknown indication from 29-dec-2022 to an unknown stop date.The consumer received her first euflexxa injection on 29-dec-2022 and experienced breast/nipple bleeding since then (beginning on an unspecified date).Additionally, she experienced "all of the local side effects too", which was further explained as localized swelling and pain to the knee.No further information was provided.The breast/nipple bleeding since then was medically significant.Action taken with euflexxa was unknown.On an unknown date, the outcome of breast/nipple bleeding since then was not recovered, the outcome of localized swelling was unknown, the outcome of pain to knee was unknown.No concomitant medication was reported.The event breast/nipple bleeding since then was reported as serious.The events localized swelling, pain to knee were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, therapy dates, route of administration; furthermore, based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's breast bleeding.Overall listedness (core label) is unlisted.Reporter causality: related company causality: not related (breast bleeding) other case numbers: internal # - others = fmc-case-000718.Internal # - others = fmc-event-000209.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.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 16215565
• MDR Text Key: 307818379
• Report Number: 3000164186-2023-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 01/18/2023

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
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female