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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 9RSP014A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Chills (2191); Decreased Appetite (4569)
Event Date 08/25/2020
Event Type  Injury  
Event Description
Loss of appetite [appetite lost]. Leg pains [leg pain]. Developed a fever of 101. 5 [fever]. Headache [headache]. Nausea [nausea]. Chills [chills]. Case narrative: initial information was received on 12-jan-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 - 9rsp014a; expiration date: 31-jul-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: no action taken 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 on 28-jan-2021 for synvisc; batch number: 9rsp014a; global ptc number (b)(4). The production and quality control documentation for lot number 9rsp014a expiration date (2022-07) was reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. Based on the lot number batch record review & lot number frequency analysis for lot number 9rsp014a no capa 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 02feb2021 there are 13 complaints on file for lot number 9rsp014 and all related sublots: 12 complaints are on file for lot number 9rsp014a: (1) foreign matter, (1) plunger issue, (2) leakage, (1) broken syringe, (1) broken syringe prior, (5) adverse events report and (1) missing syringe. 1 complaint is on file for lot number 9rsp014d: (1) other (complaint nos). Sanofi will continue to monitor complaints as stated in sop (b)(4)'product event handling' to determine if a capa is required. Final investigation was completed on 02-feb-2021. Follow up information received on 12-jan-2021 from other healthcare professional. Non-significant information. Follow up was received on 28-jan-2021 from healthcare professional. Global ptc number updated. Text amended accordingly. Additional information was received on 02-feb-2021 from other healthcare professional. Gptc results were received and added. Text was amended accordingly.
 
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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 Key11277512
MDR Text Key230226886
Report Number2246315-2021-00062
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 health professional
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number9RSP014A
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: 02/04/2021 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.
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