MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 10/26/2020

Event Description

Upon receiving the third of 3 shots in my right knee, i experienced itching/ hives all over my body, from my eyeballs to between my toes and my scalp.While not life threatening, it was exceedingly irritating from about 2 months.

• Brand Name: EUFFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 12813617
• MDR Text Key: 280936346
• Report Number: MW5105297
• Device Sequence Number: 2
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White