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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Visual Disturbances (2140); Burning Sensation (2146); Dizziness (2194); Depression (2361); Numbness (2415); Neck Stiffness (2434); Chest Tightness/Pressure (2463); Palpitations (2467); Alteration In Body Temperature (2682); No Code Available (3191)
Event Date 01/01/2017
Event Type  Death  
Event Description
Took his own life [suicide]. Knee getting worse and worse [unspecified disorder of knee joint]. Debilitating pain [pain]. Fatigue [fatigue]. Periods of breathing difficulty [difficulty breathing]. Racing heart [heart racing]. Cough [cough]. Chest pressure [chest pressure]. Stickiness inside mouth [discomfort in mouth]. Loss of coordination and balance [lack of coordination]. Loss of coordination and balance [balance difficulty]. Some short term memory loss [short-term memory loss]. Dizzy spells [dizzy spells]. Numb legs and feet [numbness of lower extremities]. Vision changes including blurring and visual movement [abnormal eye movements nos]. Vision changes including blurring and visual movement [vision blurred]. Drastic body temperature changes [body temperature abnormal]. Mood swings [mood swings]. Depression [depression]. Terrible feeling of pressure in head [head pressure]. Extreme headaches [headache]. Stiffness in neck [neck stiffness]. Could hardly walk [walking difficulty]. Intense burning that started with knee injection and burned down through lower leg [burning leg]. Intense burning that started with knee injection and burned down through lower leg [injection site burning]. Extreme tightness behind knee [joint tightness]. Case narrative: initial information received from (b)(6) on 11-dec-2018 regarding an unsolicited valid serious case received from patient's wife via health authorities of united states under reference mw5081796. This case involves a (b)(6) male patient who experienced knee getting worse and worse, debilitating pain, fatigue, periods of breathing difficulty, racing heart, cough, chest pressure, stickiness inside mouth, loss of coordination and balance, some short term memory loss, dizzy spells, numb legs and feet, extreme tightness behind knee, vision changes including blurring and visual movement, drastic body temperature changes, mood swings, depression, terrible feeling of pressure in head, extreme headaches, stiffness in neck, could hardly walk, intense burning that started with knee injection and burned down through lower leg after about a month and took his own life after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included carvedilol (coreg); trazodone; losartan; and morniflumate (flomax). On an unknown date in (b)(6) 2017, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection at an unknown dose for dosage to replace "lost" of fluid in knee from a bakers cyst burst. It was reported that patient had a bad reaction to a hylan g-f 20, sodium hyaluronate injection in his knee. It was reported that it was a bad batch and sent back to the manufacturer. Patient continued to follow doctor's orders and saw the doctor about his knee getting worse and worse, continuously got worse. The doctor just said to use paracetamol (tylenol) and use ice on knee. Patient took a list of "how he feeling". Patient was still with serous pain and other things that "was" going on with his body. Patient could hardly walk but went to the doctor and he "cannot" stand it. Patient returned to the doctor many times and he wasn't being checked out on any possible side effects he was complaining about. Patient couldn't handle it much more. On (b)(6) 2017 (a month out from the shot), patient still experienced intense burning that started with knee injection and burned down through lower leg, could hardly walk, stiffness in neck, extreme headaches, terrible feeling of pressure in head, severe depression, severe mood swings, drastic body temperature changes, vision changes including blurring and visual movement, vision changes including blurring and visual movement, extreme tightness behind knee, numb legs and feet, dizzy spells, some short term memory loss, loss of coordination and balance, stickiness inside mouth, chest pressure, cough, racing heart, periods of breathing difficulty, fatigue, debilitating pain. On an unknown date in (b)(6) 2017 (in next 44 days), patient took his own life. It is unknown if an autopsy was done. Afterwards it was notified that shot was found to be contaminated and that lot of injections were being recalled. A product technical complaint (ptc) was initiated on 14-dec-2018 for synvisc one. Batch number unknown, global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. All finished batch records for specification conformance prior to release were reviewed as per the requirement. Any out of specification result need to be identified and mitigated through the ncr process. Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals. Final investigation complete date was 14-dec-2018. No safety issues were indicated in this review. Corrective treatment: paracetamol for knee getting worse and worse; not reported for rest. The patient outcome was reported as not recovered / not resolved for all events except took his own life. Seriousness criteria: life threatening and medically significant for took his own life. Additional information was received on 14-dec-2018. Global ptc number and ptc results were added. Text amended accordingly.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key8191030
MDR Text Key131204912
Report Number2246315-2018-00752
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
Treatment
COREG (CARVEDILOL),UNKNOWN; FLOMAX [MORNIFLUMATE] (MORNIFLUMATE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; TRAZODONE (TRAZODONE),UNKNOWN
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