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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Chest Pain (1776); Dyspnea (1816); Rash (2033); Swelling (2091); Tingling (2171); Reaction (2414)

Event Type  Injury  

Event Description

Case description: this serious spontaneous device report was received from a physician in the united states.A pt, a (b)(6) female experienced anaphylactic reaction, chest pain, trouble breathing, tongue swelling, lips swelling, rash, and skin tingling sensation after receiving the euflexxa injection (1% sodium hyaluronate) to the left knee for osteoarthritis.Lot number: unspecified expiration date: unspecified.On (b)(6) 2015, the female pt initiated euflexxa therapy and received her first injection.The pt reported that she took celebrex (celecoxib) after her injection on (b)(6) 2015 and within an hour after the euflexxa injection, the pt experienced chest pain, trouble breathing, tongue swelling, lips swelling, rash, and skin tingling sensation.The pt took two benadryl (diphenhydramine hci) without relief.The pt then went to the emergency room and she was given iv epinephrine, ib solumedrol, and pepcid (famotidine) and the pt's symptoms resolved.As per reporting physician, the pt was not admitted to the hospital and that this is the first anaphylactic reaction that he had seen with euflexxa.The physician did not think that the pt's events were related to euflexxa as there were different factors that could have caused the pt's reaction like the sanitation wipes that the physician's office used for their probes that may contain certain ingredients, pt's allergic history to (b)(6), and concomitant medication celebrex that contains sulfur.Medical history was provided and included past experience of similar symptoms as reported with (b)(6).Concomitant medication was provided.Sender comment: reporter causality: not related.

• 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 ; IS
• Manufacturer Contact: 100 interpace pkwy; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 5401477
• MDR Text Key: 37336213
• Report Number: 3000164186-2016-00001
• 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
• Type of Report: Initial
• Report Date: 01/20/2016,01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/28/2015
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR