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

Lot Number 8RSL062

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

Patient Problem Cancer (3262)

Event Type  Death  

Event Description

Cancer [cancer] case narrative: this case is linked to case (b)(4) (multiple device suspect used for the same patient-case for right knee injection) and (b)(4)(multiple device suspect used for the same patient - case for right shoulder injection).Initial information received on 08-dec-2023 regarding a solicited valid serious case from a patient's caregiver, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada study title: patient support program involving synvisc one.This case involves an 86 years old male patient who had cancer while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2019, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate, 48 mg/6ml) injection at dose of 6 ml once in left shoulder (lot - 8rsl062, expiry date, route, indication: unknown).On an unknown date, after unknown latency, the patient had a cancer (neoplasm malignant, medically significant, leading to death).The care giver did not have much information other than the patient had cancer for a long time.On (b)(6) 2023, the patient passed away from cancer.It is unknown if an autopsy was done.The cause of death was reported as cancer.Action taken: not applicable it was not reported if the patient received a corrective treatment for the event (cancer).At time of reporting, the outcome was fatal for the event of cancer.Reporter causality: not reported company causality: not reportable.

Event Description

Cancer, synvisc one administered in shoulder with no reported adverse event [product administered at inappropriate site].Case narrative: this case is linked to case (b)(4) (multiple device suspect used for the same patient-case for right knee injection) and (b)(4) (multiple device suspect used for the same patient - case for right shoulder injection).Initial information received on 08-dec-2023 regarding a solicited valid serious case from a patient's caregiver, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case involves 86 years old male patient who had cancer while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].Also, the synvisc one administered in shoulder with no reported adverse event directly linked to this product administered at inappropriate site.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2019, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate, 48 mg/6ml) injection at dose of 6 ml once in left shoulder (lot - 8rsl062, expiry date: 30-sep-2021, route, indication: unknown) (product administered at inappropriate site, latency: same day).On an unknown date, after unknown latency, the patient had a cancer (neoplasm malignant, medically significant, leading to death).The care giver did not have much information other than the patient had cancer for a long time.On (b)(6) 2023, the patient passed away from cancer.It is unknown if an autopsy was done.The cause of death was reported as cancer.Action taken: not applicable for both the events.It was not reported if the patient received a corrective treatment for the event (cancer).At time of reporting, the outcome was fatal for the event of cancer, unknown for product administered at inappropriate site.Reporter causality: not reported for both the events.Company causality: not reportable for both the events.A product technical complaint (ptc) was initiated on 08-dec-2023 for synvisc one (batch number: 8rsl062, expiry date: 30-sep-2021) with global ptc number (b)(4).The sample status was not available.Preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii - (dp (unspecified abbreviation) 13dec23).The production and quality control documentation for lot # 8rsl062 expiration date (2021-09) was manufactured on 18oct18 packaged 4000 singles was reviewed.Was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 8rsl062 no capa (corrective and preventive action) is required.As of 14dec23 there are 10 complaints on file for lot# 8rsl062 and all related sub-lots.There are 8 complaints on file for lot# 8rsl062: (8) adverse event reports.1 complaint is on file for lot # 8rsl062b: (1) expiry date.1 complaint is on file for lot # 8rsl062a: (1) missing component.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 20-dec-2023 with summarized conclusion as no assessment possible.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Additional information was received on 08-dec-2023 from healthcare professional (quality department).Ptc number for lot number: 8rsl062 were added.Text amended accordingly.Additional information was received on 20-dec-2023 from healthcare professional (quality department).Ptc result along with expiry date were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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: 18320276
• MDR Text Key: 330398551
• Report Number: 2246315-2023-00114
• 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: Study,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/25/2023

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 Expiration Date: 09/30/2021
• Device Lot Number: 8RSL062
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• 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): Death; Other
• Patient Sex: Male