• 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 (3X2ML PREFILLED SYR) 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 SYNVISC (3X2ML PREFILLED SYR) ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Urticaria (2278); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Spontaneous: (b)(6), precertification representative at md office, stated pt had a bad reaction to the synvisc (rash/swelling/hives). Md will be switching pt to euflexxa. No further information was provided. Reported to (b)(6) by health professional.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNVISC (3X2ML PREFILLED SYR)
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME
MDR Report Key12475229
MDR Text Key271803122
Report NumberMW5103944
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

-
-