MAUDE Adverse Event Report: GENZYME SYNVISC

Lot Number 7RSP010E

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

Patient Problems Fainting (1847); Hypersensitivity/Allergic reaction (1907); Respiratory Distress (2045); Malaise (2359); Sweating (2444)

Event Date 05/22/2018

Event Type  Injury  

Event Description

I have recovered two rounds of the synvisc shots in each knee. First round was received on (b)(6) 2018, second round was on (b)(6) 2018. After the first round i came home and passed out and for four days i sweated thru my pj's and bedding. My husband had to get me up to go to bathroom. After second round it happened again and both times i could barely breathe. I told my doctor about it the first time and he said it was nothing. After i passed out after the second time my breathing got worse. On friday i contacted my doctor and he told me it was just the flu and that i should go to an urgent care and they would run a test to confirm it was the flu. I waited until monday and i was no better so on tuesday i contacted the urgent care he suggested and they told me it did not sound like the flu. Especially since i was not able to focus and didn't feel right. I went by my primary and i was told it didn't look good, i needed to go to the er, which i did. After extensive testing they determined i had an allergic reaction to the shots and i had developed crystals in my lungs. I was admitted and stayed in the hospital until that friday. The orto. Doctor never contacted me or come by and check on me. I did contact the manufacturer and submitted this same form to you but have not heard anything. I am still under doctor care and don't know if the damage is permanent or not. Suspect: yes. Primary: yes. Product type: drug/biologic. Strength: 2ml ml millilitres. Ndc number: (b)(4). Do you still have the product in case we need to evaluate it: yes. Quantity: 1 injection. Frequency: 1 shot/knee 3xs. How was it taken or used: 1 injection/knee.

• Brand Name: SYNVISC
• Type of Device: SYNVISC
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7544314
• MDR Text Key: 109431121
• Report Number: MW5077454
• 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

• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2018
• Device Lot Number: 7RSP010E
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/24/2018 Patient Sequence Number: 1