MAUDE Adverse Event Report: SANOFI-AVENTIS U.S. LLC SYNVISC-ONE VISCOSUPPLEMENT GEL; ACID, HYALURONIC, INTRAARTICULAR

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problems Death (1802); Emotional Changes (1831); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Respiratory Distress (2045); Tachycardia (2095); Blurred Vision (2137); Visual Impairment (2138); Burning Sensation (2146); Dizziness (2194); Depression (2361); Neck Stiffness (2434); Chest Tightness/Pressure (2463); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 01/01/2017

Event Type  Death  

Event Description

My husband had a bad reaction to a synvisc-one injection in his knee, he received at andrews-sport medicine in (b)(6) by dr (b)(6), (b)(6) 2017.It was told to us that it was a bad batch and sent back to the mfr sanofi-aventis group.He continued to follow dr's orders and saw the dr about his knee getting worse and worse.Continuously got worse, the dr just said take tylenol and use ice on knee.He took a list of how he was feeling, still with serious pain and other things that was going on with his body.He could hardly walk but went to the dr telling him he can't stand it.We returned to the dr many times and he wasn't being checked out on any possible side effects he was complaining about.My husband keep telling me and our son he couldn't handle it much more, within the next 44 days it was more than my husband of 43 years could bare, i had never seen him like this.On (b)(6) 2017, he took his own life.On (b)(6) dr (b)(6) called to say the shot was found contaminated and that the lot of injections were being recalled.At that time, it was too late to help my husband.But it all made sense as to what had taken over his body and mind and all that he was experiencing and trying to tell us.Later i found out that the drs may have known earlier, as the recall had been announced in a press release on december 11th, yet we weren't told in time to have saved my husband's life.A month out from his shot his horrible adverse reaction he still had debilitating pain, fatigue, periods of breathing difficulties, racing heart and cough, chest pressure, stickiness inside his mouth, loss of coordination and balance and some short term memory loss, dizzy spells, intense burning that started with his knee injection and burned down through the lower leg, numb legs and feet, extreme tightness behind the knee, vision changes including blurring and visual movement, drastic body temperature changes, severe mood swings and depression and a terrible feeling of pressure in his head, extreme headaches, stiffness in his neck.I have lots of notes but will stop now until you want more info.How was it taken or use? subcutaneous; date the person first started taking or using the product: (b)(6) 2017; date the person stopped taking or using the product: (b)(6) 2017.Reason for use: replace lost of fluid in his knee from a bakers cyst burst.

• Brand Name: SYNVISC-ONE VISCOSUPPLEMENT GEL
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SANOFI-AVENTIS U.S. LLC
• MDR Report Key: 8128888
• MDR Text Key: 129436250
• Report Number: MW5081796
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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
• Treatment: COREG 6.25 MG; FLO-MAX 0.4 MG; LOSARTAN 100 MG; TRAZODONE 100 MG; TYLENOL
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 68 YR
• Patient Weight: 76