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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144); Dizziness (2194); Sweating (2444)

Event Date 08/19/2003

Event Type  Injury  

Event Description

Began feeling dizzy and sweaty [sweaty], nausea and vomiting [vomiting], began feeling dizzy and sweaty [dizzy], nausea and vomiting [nausea].Case narrative: this case is linked to case (b)(4) (multiple devices, 2nd injection).(2nd: second) initial information was received on 14-dec-2020 regarding an unsolicited valid serious case from a pharmacist via health authorities of united states under reference mw5097796.This case involves a patient (with unknown demographics) who began feeling dizzy and sweaty and had nausea and vomiting, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On (b)(6) 2003, the patient received first injection of synvisc (hylan g-f 20, sodium hyaluronate) via intra-articular route (lot number/expiration date: unknown) (dose, frequency and indication: unknown).There will be no information available on the batch number of this case.On same day after the first injection, the patient began feeling dizzy (dizziness) and sweaty (hyperhidrosis).The patient then experienced nausea and vomiting (vomiting, nausea; latency: same day).Reaction happened again during 2nd injection.The patient required hospitalization for all the events for fluid replacement and monitoring.Final diagnosis was nausea and vomiting and began feeling dizzy and sweaty.Action taken: no action taken for all the events.Corrective treatment: fluid replacement in hospital for all the events.The patient outcome is reported as unknown for all the events.Seriousness criteria: hospitalization for all the events, and intervention required for sweaty.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa was required.Investigation complete date: 23-dec-2020.Additional information was received on 28-dec-2020 from other healthcare professional (genzyme event management group).Lot number updated to unknown as it was confirmed as invalid.Global ptc number and its results were added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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 Key: 11100335
• MDR Text Key: 231577866
• Report Number: 2246315-2020-00196
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention