MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. ELFLEXXA; EUFLEXXA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/04/2018

Event Type  No Answer Provided  

Event Description

Injected in both knees with euflexxa left leg got infected and could not move leg- scoped leg on (b)(6) 2018 to see what kind of infection.Put on antibiotic through pic line on (b)(6) 2018 bleeding internally from zerelto.Had 5 pints of blood.Hospitalized for 7 days.Rehab for 7 days.Now at home rehab for 1 month.Date the person first started taking or using the product: (b)(6) 2018.Date the person stopped taking or using the product: (b)(6) 2018.

• Brand Name: ELFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 7556624
• MDR Text Key: 109791759
• Report Number: MW5077555
• Device Sequence Number: 1
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 73