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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME SYNVISC

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GENZYME SYNVISC Back to Search Results
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.
 
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Brand NameSYNVISC
Type of DeviceSYNVISC
Manufacturer (Section D)
GENZYME
MDR Report Key7544314
MDR Text Key109431121
Report NumberMW5077454
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Lot Number7RSP010E
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
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