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

Lot Number CRSL027B

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

Patient Problems Arthritis (1723); Pain (1994); Arthralgia (2355); Superficial (First Degree) Burn (2685); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/23/2023

Event Type  Injury  

Event Description

Swelling post injection.Redness post injection [injection site redness].Pain post injection.Heat post injection [injection site warmth].Case narrative: initial information received on 30-jan-2023 from australia regarding an unsolicited valid serious case received from a other health professional.This case involves a 50 years old and unknown gender patient who had swelling post injection, redness post injection, pain post injection and heat post injection with the use of 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) 2023, the patient received synvisc one injection at a dose of 6 ml once (lot: crsl02yb and expiry date: 30-jun-2025) (route, strength: unknown) for knee pain.On (b)(6) 2023 after a latency of same day swelling post injection, redness post injection, pain post injection and heat post injection (injection site swelling), (injection site erythema), (injection site pain), (injection site warmth) (seriousness criteria: medically significant) patient visited their gp (general physician) and was prescribed antibiotics.Action taken: not applicable for all the events.Corrective treatment: antibiotics for all the events.Outcome: recovering/resolving for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 05-feb-2023: this case involves a 50 years old and unknown gender patient who had swelling post injection, redness post injection, pain post injection and heat post injection with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].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, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Swelling post injection [injection site joint swelling] pain post injection [injection site joint pain] redness post injection [injection site joint redness] heat post injection [injection site joint warmth].Case narrative: initial information was received on 30-jan-2023 from australia regarding an unsolicited valid serious case from a health professional.This case involves 50 years old patient of unknown gender who experienced swelling, redness, pain and heat post injection with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), and family history were not provided.On (b)(6) 2023, the patient received synvisc one injection at a dose of 6 ml once via intra-articular route (lot: crsl027b and expiry date: 30-jun-2025, strength: 48mg/6ml) for knee pain.On (b)(6) 2023 after a latency of same day swelling, redness, pain and heat post injection (injection site joint swelling, injection site joint erythema, injection site joint pain, injection site joint warmth) (seriousness criteria: medically significant) patient visited their gp (general physician) and was prescribed antibiotics.Action taken: not applicable for all the events.Corrective treatment: antibiotics for all the events.Outcome: recovering for all the events.A product technical complaint (ptc) was initiated on 31-jan-2023 for synvisc one (batch number: crsl027b; expiry date: 30-jun-2025) with global ptc number 100331978.The sample status was not available.Ptc was set in process and results were pending for the same.Additional information was received on 31-jan-2023 from healthcare professional (quality department).Ptc number for lot number: crsl027b (updated) along with strength were added.Text amended accordingly.

Event Description

Redness post injection [injection site joint redness] swelling post injection [injection site joint swelling] pain post injection [injection site joint pain] heat post injection [injection site joint warmth] case narrative: initial information was received on 30-jan-2023 from australia regarding an unsolicited valid serious case from a health professional.This case involves 50 years old patient of unknown gender who had swelling, redness, pain and heat post injection with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), and family history were not provided.On (b)(6) 2023, the patient received synvisc one injection (liquid solution) at a dose of 6 ml once via intra-articular route (lot: crsl027b and expiry date: 30-jun-2025, strength: 48mg/6ml) for knee pain.On (b)(6) 2023 after a latency of same day swelling, redness, pain and heat post injection with (injection site joint swelling, injection site joint erythema, injection site joint pain, injection site joint warmth) (seriousness criteria: medically significant) patient visited their gp (general physician) and was prescribed antibiotics.Action taken: not applicable for all the events.Corrective treatment: antibiotics (unspecified) for all the events.Outcome: recovering for all the events.A product technical complaint (ptc) was initiated on 31-jan-2023 for synvisc one (batch number: crsl027b; expiry date: 30-jun-2025) with global ptc number 100331978.The sample status was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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.Investigation: batch number: crsl027b, synvisc one was manufactured on 18-jul-2022 with expiration date of 30-jun-2025 yielding 2,180 singles.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the nonconforming material or product process.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Customer sample was not available.Root cause could not be determined.Trend analysis: there are a total of 11 complaints for mother lot crsl027 and sub-batches.00264127 crsl027b leaflet missing 100271615 crsl027a adverse event 100271616 crsl027a adverse event 100276081 crsl027a adverse event 100277114 crsl027a adverse event 100277115 crsl027a adverse event 100278191 crsl027a adverse event 100305205 crsl027a adverse event 100326387 crsl027a without / not enough effect 100328018 crsl027a adverse event 100331978 crsl027b adverse event this review had not indicated any safety issue.Based on investigation and trend analysis, no capa (corrective and preventive action) required.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis to determine if a capa is required.The final investigation was completed on 15-jun-2023 and the summarized conclusion was "no assessment possible".Additional information was received on 31-jan-2023 from healthcare professional (quality department).Ptc number for lot number: crsl027b (updated) along with strength were added.Text amended accordingly.Additional information was received on 15-jun-2023 from a healthcare professional (quality department).Ptc investigation summary added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 16305090
• MDR Text Key: 308865047
• Report Number: 2246315-2023-00008
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSL027B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention; Other