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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ
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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.
 
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 liquid, (solution), 16 mg/2 ml in left knee (lot - 9rsp012a; 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.Follow up information was received on 28-jan-2021 and 22-jul-2021 from other healthcare professional.No significant information was received.Additional information was received on 27-jul-2021 from other healthcare professional.Formulation and strength.Text amended accordingly.
 
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 liquid, (solution), 16 mg/2 ml in left knee (lot - 9rsp012a; 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 product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number: 9rsp012a.Device not returned.The production and quality control documentation for lot 9rsp012a expiration date may-2022 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsp012a no capa (corrective and preventive action) is required.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.As of (b)(6) 21 there are (b)(4) complaints on file for lot# (number) 9rsp012 and all related sublots.11 complaints are on file for lot# 9rsp012a: (7) adverse event reports, (1) plunger defect and (3) leakage.5 complaints are on file for lot # 9rsp012: (1) leakage, (1) luer lok hub defect, (1) foreign matter (red particle), (1) broken syringe and (1) adverse event.2 complaints are on file for lot #9rsp012b: (2) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: (b)(6) 2021 with summary code as no assessment possible.Follow up information was received on 28-jan-2021 and 22-jul-2021 from other healthcare professional.No significant information was received.Additional information was received on 27-jul-2021 from other healthcare professional.Formulation and strength.Text amended accordingly.Additional information was received on 03-aug-2021 from healthcare professional.Global ptc results and number added.Text was amended accordingly.
 
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Brand Name
SYNVISC
Type of Device
MOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date05/31/2022
Device Lot Number9RSP012A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/28/2021
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received08/02/2021
08/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASA (ASA),UNKNOWN; ASA (ASA),UNKNOWN; ASA (ASA),UNKNOWN; ATIVAN (LORAZEPAM),UNKNOWN; ATIVAN (LORAZEPAM),UNKNOWN; ATIVAN (LORAZEPAM),UNKNOWN; COZAAR (LOSARTAN POTASSIUM),UNKNOWN; COZAAR (LOSARTAN POTASSIUM),UNKNOWN; COZAAR (LOSARTAN POTASSIUM),UNKNOWN; CRESTOR (ROSUVASTATIN CALCIUM),UNKNOWN; CRESTOR (ROSUVASTATIN CALCIUM),UNKNOWN; CRESTOR (ROSUVASTATIN CALCIUM),UNKNOWN; ESTRADIOL (ESTRADIOL),VAGINAL CREAM; ESTRADIOL (ESTRADIOL),VAGINAL CREAM; ESTRADIOL (ESTRADIOL),VAGINAL CREAM; FLECAINIDE (FLECAINIDE),UNKNOWN; FLECAINIDE (FLECAINIDE),UNKNOWN; FLECAINIDE (FLECAINIDE),UNKNOWN; FLONASE [FLUTICASONE PROPIONATE],NASAL SPRAY; FLONASE [FLUTICASONE PROPIONATE],NASAL SPRAY; FLONASE [FLUTICASONE PROPIONATE],NASAL SPRAY; GLUCOPHAGE [METFORMIN] (METFORMIN),UNKNOWN; GLUCOPHAGE [METFORMIN] (METFORMIN),UNKNOWN; GLUCOPHAGE [METFORMIN] (METFORMIN),UNKNOWN; METOPROLOL XL (METOPROLOL TARTRATE),UNKNOWN; METOPROLOL XL (METOPROLOL TARTRATE),UNKNOWN; METOPROLOL XL (METOPROLOL TARTRATE),UNKNOWN; TAGAMET [CIMETIDINE] (CIMETIDINE),UNKNOWN; TAGAMET [CIMETIDINE] (CIMETIDINE),UNKNOWN; TAGAMET [CIMETIDINE] (CIMETIDINE),UNKNOWN; TRAMADOL (TRAMADOL),UNKNOWN; TRAMADOL (TRAMADOL),UNKNOWN; TRAMADOL (TRAMADOL),UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN; 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.
Patient Outcome(s) Other; Required Intervention;
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