MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC (30 MG/2 ML)

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

Patient Problems Death (1802); Diarrhea (1811); Dyspnea (1816); Nausea (1970); Vomiting (2144)

Event Date 12/18/2015

Event Type  Death  

Event Description

On (b)(6) 2015, i, (b)(6), lost my dear mother, (b)(6), to the negligence of your clinic - (b)(64.Having been a (b)(6) in great physical condition (with exception of the knee pain), did suffer from kidney disease and chronic heart failure as so indicated in her medical bio.However, (b)(4) administration of the hyalunan injection - orthovisc caused her wrongful death.Hyalunan is known to cause nausea, vomiting, diarrhea and shortness of breath - all of which mrs.(b)(6) experienced in her last 2 weeks of life.In fact, dr.(b)(6), according to my recollection, mrs.(b)(6) contacted (b)(4), (b)(6) 2015 to inform the clinic of her illnesses/complications.She further explained some of her allergies, and was told if one in particular had gone into her bloodstream she would be a "goner".Quite an insensitive phrase - possibly some medical satire of poor taste, but that she is.A "goner"! during this same conversation, she requested product information to present to her nephrologist, dr.(b)(6) for review.Saddened the burden of this responsibility was left to the patient.How was it even possible (b)(4) would begin the first injection during an initial consultation without prior consultation with one of her physicians? this negligence of (b)(4).Improper intake process and poor record keeping, does not even have the (b)(6) 2015 conversation documented.Mrs.(b)(4) recovery also lack medical history with allergies, and vital signs before and after each injection have not been recorded.Was there really any care to your services, or was (b)(4) decision to act so hastily by taking her health and well-being into its own hands as a driven desire to meet a particular quota? perhaps little did you know, the rooster combs found in orthovisc can cause death.However, this critical information does not even appear as a warning or precaution in the literature (b)(4) distributes to its patients.Hyalunan is known to cause nausea, vomiting, diarrhea and shortness of breath - all of which mrs.(b)(6) experienced in her last 2 weeks of life.(b)(4) noted the excellent insurance coverage mrs.(b)(6) held with mail handlers and medicare - no out of pocket expense, and felt her to be a prime specimen to expedite at first sight.Not one treatment plan but two.Left and right knees.My accusations may be strong as such, dealing with my grief, but dr.(b)(6), even in your follow up recorded message to mrs.(b)(6) on (b)(6) after her (b)(6) missed appointment - (which subsequently is not documented in her records either), you were more interested in getting her back to the office for continued treatments.Not once, not twice, but three times you mentioned in the brief recording of continuing her injections even if she was having problems you felt (without actually knowing) they were minor concerns but could be addressed.Shouldn't your concerns have been more to investigate, instead of retain.This lack of patient care only demonstrates the greed of (b)(4) at the expense of a loved one's life.I suppose better protocol and intake procedures should be implemented before someone else loses a life.At (b)(6) dollars per injection.Just reel them in and shoot them up! quantity: other - 3 injections.Frequency: other - weekly.How was it taken or used: other - injection to the knee.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Do you still have the product in case we need to evaluate it: no.Knee pain - an alternative to surgery.

• Brand Name: ORTHOVISC (30 MG/2 ML)
• Type of Device: ORTHOVISC (30 MG/2 ML)
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 6587033
• MDR Text Key: 75961205
• Report Number: MW5069972
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• 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 Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 81