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

MAUDE Adverse Event Report: GENZYME SYNVISC-ONE

  • 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 SYNVISC-ONE Back to Search Results
Lot Number 7RSL021
Event Date 12/04/2017
Event Type  Injury  
Event Description

Reporter stated that she had surgery back in (b)(6) for a torn meniscus which led to fluid accumulation and swelling. Pt said she had fluid extraction thrice and two steroid shots. On (b)(6) 2017, the dr placed cushion (injection) due to pain and fluid accumulation. According to pt, upon stepping off of the table after receiving the injection, she stumbled and her knees were unable to support her weight. Reporter says on (b)(6) 2017, she decided to visit her dr due to persistent pain. During that visit, another fluid extraction was done. Reporter says she was then placed on antibiotic (bactrim) due to infection. Then on tuesday of (b)(6) 2017, reporter states that she was contacted by the dr's nurse who informed her that the injection she received on (b)(6) 2017 is part of a batch that has been recalled by fda for contamination. Reporter says the mfr of this device (injection) owes her for the misery and discomfort that she has and continues to live with. Reporter says she has lost the ability to do anything even taking care of herself.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNVISC-ONE
Type of DeviceSYNVISC-ONE
Manufacturer (Section D)
GENZYME
MDR Report Key7209040
Report NumberMW5074689
Device Sequence Number1
Product CodeMOZ
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device LOT Number7RSL021
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
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

-
-