MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Reaction (2414)

Event Date 02/05/2018

Event Type  Injury  

Event Description

Physician, dr (b)(6), a fantastic and very honest person injected hyaluronic acid which is constituted with a different form of bacteria as opposed to rooster combs in a series of three injections, the first round was fine.The second round 1/2 days later, i developed an allergic reaction, whole body rash, itching, pain.It resolved with topical steroids and a low round of prednisone.This drug euflexxa is formulated differently from previous hyaluronic injections i have received twice prior with no side effects.We just wanted you to know about this reaction, we know it is new on the market.Thanks for your time.I am a pharmaceutical sales rep retired.Severe osteoarthritis of both knees bone on bone.Date the person started taking or using the product: (b)(6) 2018.Date the person stopped taking or using the product: (b)(6) 2018."did the problem stop after the person reduced the dose or stopped taking or using the product: yes.".

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING PHARMACEUTICALS
• MDR Report Key: 7273307
• MDR Text Key: 100310032
• Report Number: MW5075269
• 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: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• 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 Outcome(s): Disability
• Patient Weight: 95