• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORP. SYNVISC-ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENZYME CORP. SYNVISC-ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Pain (1994)
Event Date 11/21/2018
Event Type  Injury  
Event Description
Pt had her injection of synvisc one for her right knee on friday (b)(6) 2018. She followed all the post-op instruction in respect to rest and not putting any weight on the affected knee but now she is reporting that the knee is very painful and she described the pain is severe. She said the injection site looks normal. Also there is no swelling at the injection site or around her knee and her knee looks normal. She stated that past the first 48 hours after the injection, she hasn't seen any improvement and it feels like it is getting worse. Route: intra-articular. Dates of use: (b)(6) 2018. Is the product compounded? no; is the product over-the-counter? no.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNVISC-ONE INJ 8MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORP.
MDR Report Key8138682
MDR Text Key129754610
Report NumberMW5081886
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 Pharmacist
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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

-
-