MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. / FERRING PHARMACEUTICALS, INC. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Lot Number R13626A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/04/2020

Event Type  Injury  

Event Description

Progressive debilitating left knee swelling, pain, and persistent effusion; right mtp pain beginning 1 week after injection with euflexa.Euflexa injections on (b)(6) 2020.Multiple joint aspirations, synovial biopsy all negative cultures (bacterial, fungal, mycobacterial), negative broad range pcr testing.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. / FERRING PHARMACEUTICALS, INC.
• MDR Report Key: 11453220
• MDR Text Key: 239166405
• Report Number: MW5099881
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: R13626A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 62 YR
• Patient Weight: 51