MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA; ACID, HYALURONIC, INTRAATICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Skin Inflammation (2443)

Event Date 03/01/2020

Event Type  Injury  

Event Description

Reporter has arthritis in her knees.She was given a steroid injection for the pain.Her doctor later told her about euflexxa injection.She was told that she will be given three injections - once a week for three weeks.After the first injection, reporter started experiencing pain in the injection site and complains to her doctor about the pain and decided to wait for another week before getting the second injection.Because this procedure happened during the covid lock down.Reporter waited another two months before getting back to the doctor's office for her third injection.She was told that she will have to start all over.She now have a total of five (5) euflexxa injections.After taking this injections she started developing lumps in her right calf.Few days later she noticed the same lumps in her left leg.She visited her doctor and a biopsy was taken from her left leg and she was diagnosed with panniculitis.Reporter believes that the panniculitis is as a result of the eufllexxa injection.She believes she is reacting to the euflexxa gel.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAATICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
• MDR Report Key: 10733376
• MDR Text Key: 213473228
• Report Number: MW5097449
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/23/2020

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 119