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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNVISC ACID, HYALURONIC

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SYNVISC ACID, HYALURONIC Back to Search Results
Lot Number 7RSL021
Device Problem Insufficient Information (3190)
Patient Problems Loss of Range of Motion (2032); Therapeutic Effects, Unexpected (2099)
Event Date 12/09/2017
Event Type  Injury  
Event Description
Development of knee effusion with restriction of flexion, onset approx 24 hours after injection. Route: intra-articular. Therapy start date: (b)(6) 2017.
 
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Brand NameSYNVISC
Type of DeviceACID, HYALURONIC
MDR Report Key7120715
MDR Text Key95059650
Report NumberMW5074006
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 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
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: 12/14/2017 Patient Sequence Number: 1
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