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

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ

  • 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 CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Arthralgia (2355); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Unable to bend [joint range of motion decreased] unable to stand [difficulty in standing] muscle spasms [muscle spasms] knees were unable to support to walk [unable to walk] severe swelling [swelling of l knee] pain in both knees [aching (l) knee]. Case narrative: this case was cross linked with case: (b)(4) (multiple devices, 2nd injection). Initial information received on 28-sep-2021 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference number: mw5102783. This case involves patient of unknown demographics who experienced knees were unable to support to walk, unable to stand, muscle spasms, severe swelling,unable to bend and pain in both knees while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included levothyroxine (levothyroxine); losartan (losartan); spironolactone (spironolactone); cetirizine hydrochloride (cetrizine); vitamin d (vitamin d nos); multivitamin (vitamin nos) and chlorphenamine maleate, paracetamol, phenylpropanolamine hydrochloride (cologen). On the unknown date of 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, batch number, route, indication, frequency: unknown) in left knee. On the unknown date of 2021, after the latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced severe swelling (joint swelling) and pain in left knee (arthralgia), unable to support to walk (gait inability), unable to stand (dysstasia) and muscle spasms (muscle spasm). Patient had elevated iced and but patient was unable to bend (joint range of motion decreased). The pain began under the knee caps seven hours after the injections and continued to extreme swelling surrounding both the knees. Patient took ibuprofen and cyclobenzaprine. Action taken: unknown for all the events. Corrective treatment: ibuprofen and cyclobenzaprine for muscle spasms and arthralgia; not reported for rest all the events outcome: unknown for all the events. Seriousness criteria: medically significant and intervention required for all events a product technical compliant was initiated and results were pending same.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNVISC
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
MDR Report Key12573219
MDR Text Key282045698
Report Number2246315-2021-00161
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
Treatment
CETRIZINE (CETIRIZINE HYDROCHLORIDE),UNKNOWN; CETRIZINE (CETIRIZINE HYDROCHLORIDE),UNKNOWN; COLOGEN,UNKNOWN; COLOGEN,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; MULTIVITAMIN [VITAMINS NOS],UNKNOWN; MULTIVITAMIN [VITAMINS NOS],UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN
-
-