MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Nerve Damage (1979); Pain (1994); Skin Discoloration (2074); Swelling (2091); Vertigo (2134); Visual Disturbances (2140); Burning Sensation (2146); Anaphylactoid (2218); Toxicity (2333); Arthralgia (2355); Reaction (2414); Numbness (2415)

Event Date 03/30/2017

Event Type  Injury  

Event Description

Left hip joint injected with euflexxa and cortisone at a surgery center (b)(6) 2016.Anaphylaxis occurred from euflexxa.Massive systemic reaction.Symptoms included throat closing, hoarse voice, itching, flushing, swelling of face, purple foot soles, left side of face purple, the feeling of being poisoned (toxic), mouth burning, tongue raw and swollen plus horrible taste which continues, visual disturbances, foul smelling urine and feces.Treated with steroids and antihistamines for 5 days.Even with treatment my symptoms did not resolve, in fact, new symptoms appeared each day.Urgent care, er could not resolve problems.Allergist said the drug was too high in sodium for my system.Toxicity off the charts.Neurologic damage to vision, facial nerves, vertigo, balance issue.Systemic joint pain continues.Awaiting rheumatoid consult.Pain in hip is excruciating since injection.Nerve pain plus numbness in leg and foot.Clearly my joint has been damaged and continues to be damaged from this toxic substance/poisonous substance.After injection i continue to have symptoms.However, the joint pain, inability to be wait bearing/ mri results all point to joint degeneration from this medication.I am in agony and the medical community cannot access data of what this drug continues as it degrades my joint.No transparency from fda or drug manufacturer (ferring usa) to assist patient when things go horribly wrong.If doctors were given access to trial data which showed how adverse reactions were remedied then perhaps we could stop the damage to my joint.Perhaps the systemic ongoing damage to my body could be halted while it currently marches on destroying me.I was a healthy athlete on zero medications prior to this injection.I do not smoke or drink and am a life-long vegetarian.Now, i am in agony and crippled by a drug the fda approved as "safe." there is nothing safe about this drug if you are sitting in my shoes.Actually, i realize the fda approves drugs based on statistics.Therefore its acceptable to injure, kill, or cripple a few people and approve a drug.It's a numbers game, right? statistically speaking, i fell into those harmed but "acceptable." would this be acceptable if it was your family member? i ask that this drug be recalled as it is a dangerous substance.Please do your job by protecting people from dangerous substances and demanding that patients be given "informed consent" prior to receiving any injectable and oral medications.How was it taken or used: other: joint injection.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Why was the person using the product: was a 1 time injection performed in operating room by dr.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 6525831
• MDR Text Key: 73953021
• Report Number: MW5069371
• 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: Other
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE.; RX MEDS: ALLEGRA 180; TYLENOL
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Weight: 50