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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Local Reaction (2035); Skin Discoloration (2074); Thrombosis (2100); Inadequate Pain Relief (2388)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

This serious case concerns a patient who was hospitalized due to local allergic reaction (lumps with white color at the synovia), local inflammatory reaction (edema all over the leg) and pain following treatment with euflexxa.Hospitalization included hypothesis of thrombosis, circulatory system examination and thrombosis medication.Bacterioscopy, culture and antibiogram of the white lumps in synovia did not show any abnormality.Causality to local allergic reaction (lumps with white color at the synovia) is unassessable due to lack of information and unlisted.Pain and leg oedema are potential sequelae to the local knee inflammatory reaction and related.Pain is listed while leg oedema (local inflammatory reaction) is unlisted.

Event Description

Local allergic reaction (lumps with white color at the synovia) (hypersensitivity).Local inflammatory reaction (edema all over the leg) (inflammation) pain.Case description: this serious, spontaneous report was received from a physician via a daiichi-sankyo sales representative in (b)(4).The patient, (b)(6) male, experienced severe pain, local inflammatory reaction characterized as edema all over the leg and local allergic reaction characterized as lumps with white color at the synovia after treatment with euflexxa (sodium hyaluronate) for an unknown indication (start date unknown).A physician reported to a daiichi-sankyo sales representative on (b)(4) 2015 that a (b)(6) male patient reported lumps at the synovia during treatment with euflexxa (indication and batch number were not informed).The reporter informed that he administered two injections of euflexxa.It was not informed in which part of the body the medication was applied.The physician informed that the patient experienced severe pain (it was not informed where he was feeling the pain).So, an arthroscopy was performed and it showed lumps at the synovia.Another physician reported to daiichi-sankyo sales representative on (b)(4) 2015 that the patient experienced local inflammatory reaction three weeks ago ((b)(6) 2015).It was informed that this local inflammatory reaction was becoming severe with edema all over the leg (it was not informed in which leg this adverse event occurred).The reporter informed that the hypothesis of thrombosis was raised due to the severity of this adverse event.He also informed that exams of the circulatory system (it was not precise which exams were performed) were performed and they did not show any abnormality.The reporter informed that the adverse event was becoming more severe and the patient was hospitalized and medication for thrombosis was administered (it was not informed which trade and/or generic name).The physician also reported that an arthroscopy was performed and it showed a local allergic reaction with lumps with white color at the synovia.These lumps were collected and the material was sent to the analysis.At the analysis laboratory, bacterioscopy, culture and antibiogram were performed and all of these tests did not show any abnormality.The reporter also informed the patient still presents pain (it was not informed where he was feeling the pain) and it was not informed if other adverse events are still ongoing.Relevant medical history and concomitant therapy were not informed.Additional information received (b)(4) 2015 from another physician: additional adverse event of local inflammatory reaction (edema all over the leg), laboratory test, additional exams and event outcome of pain.Reporter causality: related; company causality: related; overall listedness: unlisted.(b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; kiryat malachi ; IS
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; p.o. box 571; kiryat malachi 83104 ; IS 83104
• Manufacturer Contact: 100 interpace pkwy; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 5065123
• MDR Text Key: 25713728
• Report Number: 3000164186-2015-00023
• 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: foreign,health professional
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 08/11/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR