• 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
Lot Number 9RSP012A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Chills (2191); No Code Available (3191); Decreased Appetite (4569)
Event Date 08/25/2020
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment dated (b)(6) 2021: this case involves an adult patient (gender: unknown) who experienced loss of appetite, leg pains, developed a fever of 101. 5, headache, nausea and chills, after receiving medical device hylan g-f 20, sodium hyaluronate (synvisc). Based on the available information, causal relationship between the events and suspect product could not be denied. However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.
 
Event Description
Loss of appetite [appetite lost]. Leg pain [leg pain]. Chills [chills]. Headache [headache]. Nausea [nausea]. Fever 101. 5 [fever]. Case narrative: initial information was received on (b)(6) 2021 regarding an unsolicited valid serious case from a patient via health authorities of united states under reference mw5098261. This case involves an adult patient (gender: unknown) who experienced loss of appetite, leg pains, developed a fever of 101. 5, headache, nausea and chills, after receiving 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 losartan potassium (cozaar); cimetidine (tagamet); flecainide; fluticasone propionate (flonase); metformin (glucophage); metoprolol tartrate (metoprolol xl); lorazepam (ativan); rosuvastatin calcium (crestor); tramadol; estradiol (estradiol); asa; and vitamin d nos (vitamin d). In 2020, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection in left knee (lot - 9rspo12a; expiration date:31-may-2022) (dose, frequency, indication: unknown). On (b)(6) 2020, after unknown latency, the patient developed a fever of 101. 5 (pyrexia), headache, nausea, chills, loss of appetite (decreased appetite) and leg pains (pain in extremity). These symptoms lasted on and off treated with paracetamol (tylenol) prn (as needed) through 2020. These events were assessed as medically significant. Final diagnosis was chills, nausea, headache, developed a fever of 101. 5, leg pains and loss of appetite. Action taken: unknown for all the events. The patient was treated with paracetamol (tylenol) for chills, headache, developed a fever of 101. 5, leg pains, not reported for nausea and loss of appetite. The patient outcome is reported as unknown for all the events. A product technical complaint (ptc) was initiated with global ptc number (b)(4), and the results were pending for the 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
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key11242224
MDR Text Key229084394
Report Number2246315-2021-00044
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,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number9RSP012A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/28/2021 Patient Sequence Number: 1
Treatment
ASA (ASA), UNKNOWN.; ATIVAN (LORAZEPAM), UNKNOWN.; COZAAR (LOSARTAN POTASSIUM), UNKNOWN.; CRESTOR (ROSUVASTATIN CALCIUM), UNKNOWN.; ESTRADIOL (ESTRADIOL), VAGINAL CREAM.; FLECAINIDE (FLECAINIDE), UNKNOWN.; FLONASE [FLUTICASONE PROPIONATE], NASAL SPRAY.; GLUCOPHAGE [METFORMIN] (METFORMIN), UNKNOWN.; METOPROLOL XL (METOPROLOL TARTRATE), UNKNOWN.; TAGAMET [CIMETIDINE] (CIMETIDINE), UNKNOWN.; TRAMADOL (TRAMADOL), UNKNOWN.; VITAMIN D [VITAMIN D NOS], UNKNOWN.
-
-