MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL / FERRING PHARMACEUTICAL, INC. EUFLEXXA 1% SODIUM HYALURONATE; HYALURONATE ACID

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091)

Event Date 02/20/2017

Event Type  Injury  

Event Description

Bleeding on brain, right knee extreme pain, chest, shoulders.Severe fall in my apt 5:20am on (b)(6) 2017.Two cracked ribs.Hospitalized, sent astoria rehab for 3 weeks.Extreme pain, swelling, very tired.Slept 3 hours after 3rd injection (b)(6) 2017.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017."why was the person using the product: dr (b)(6) injected in my right knee (3 weeks period).Did the problem return if the person started taking or using the product again: yes.".

• Brand Name: EUFLEXXA 1% SODIUM HYALURONATE
• Type of Device: HYALURONATE ACID
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL / FERRING PHARMACEUTICAL, INC.
• MDR Report Key: 6600807
• MDR Text Key: 76401199
• Report Number: MW5070072
• 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: 05/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 108