MAUDE Adverse Event Report: SANOFI-AVENTIS US LLC SYNVISCONE

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

Patient Problems Skin Discoloration (2074); Tachycardia (2095); Chills (2191); Reaction (2414)

Event Date 07/29/2017

Event Type  Injury  

Event Description

Other serious/important medical incident: severe allergic reaction.I received a synvisc-1 shot on (b)(6) 2017.That night, my heart started racing a little and by the next night it was worse.On saturday, (b)(6) my husband took me to the local er since i was suffering from chills, dry mouth, and flushing of my skin.After the er doctor ran tests and had an ekg performed and talked with the orthopaedic doctor on call for the doctor that administered the shot, it was determined that i had a severe allergic reaction to the synvisc-1 shot.Date the person first started taking or using the product: (b)(6) 2017.Did the person stop after the person reduced the dose or stopped taking or using the product: no.Did the problem return if the person started taking or using the product again: yes.Do you still have the product in case we need to evaluate it: no.Why was the person using the product: it was being used to treat the meniscus tear and arthritis.

• Brand Name: SYNVISCONE
• Type of Device: SYNVISCONE
• Manufacturer (Section D): SANOFI-AVENTIS US LLC
• MDR Report Key: 6794150
• MDR Text Key: 82817209
• Report Number: MW5071577
• 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: Patient
• Type of Report: Initial

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 54