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

Lot Number UNKNOWN

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Bedridden, inflamed ([inflammation nos), painful reaction (pain).Case narrative: initial information received on (b)(6) 2021 from (b)(6) regarding an unsolicited valid social media serious case received from a consumer/non-hcp.This case involves adult female patient who experienced bedridden, inflamed and painful reaction while being treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection, (strength, batch number, route, frequency: unknown).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had painful reaction (pain) due to synvisc infiltration.Patient was inflamed (inflammation) and was bedridden (disability) for a nearly a week.Action taken with hylan g-f 20, sodium hyaluronate (synvisc) was unknown.It was not reported if the patient received a corrective treatment for the events (inflamed, bedridden, painful reaction).Outcome: recovered for bedridden; unknown for both the events.

Event Description

Bedridden [bedridden].Inflamed [inflammation nos].Painful reaction [pain].Case narrative: initial information received on 16-oct-2021 from canada regarding an unsolicited valid social media serious case received from a consumer/non-hcp.This case involves adult female patient who experienced bedridden, inflamed and painful reaction while being treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection, (strength, batch number, route, frequency: unknown).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had painful reaction (pain) due to synvisc infiltration.Patient was inflamed (inflammation) and was bedridden (disability) for a nearly a week.Action taken with hylan g-f 20, sodium hyaluronate (synvisc) was unknown.It was not reported if the patient received a corrective treatment for the events (inflamed, bedridden, painful reaction).Outcome: recovered for bedridden; unknown for both the events.A product technical complaint (ptc) was initiated with global ptc number: (b)(4) on 24-dec-2021 for product.Batch number: unknown.Sample status: not available.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.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.Final investigation complete date was 10-jan-2022.No safety issues were indicated in this review.Additional information was received on 10-jan-2022 from the quality department.Global ptc number and ptc result added.Text amended accordingly.

Event Description

Bedridden, inflamed [inflammation nos], painful reaction [pain].Case narrative: initial information received on 16-oct-2021 from canada regarding an unsolicited valid social media serious case received from a consumer/non-hcp.This case involves adult female patient who experienced bedridden, inflamed and painful reaction while being treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection, (strength,: 16mg/2ml, batch number, route, frequency: unknown).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had painful reaction (pain) due to synvisc infiltration.Patient was inflamed (inflammation) and was bedridden (disability) for a nearly a week.Action taken with hylan g-f 20, sodium hyaluronate (synvisc) was unknown.It was not reported if the patient received a corrective treatment for the events (inflamed, bedridden, painful reaction).Outcome: unknown for painful reaction; recovered for both the events.A product technical complaint (ptc) was initiated with global ptc number: 100185703 on 24-dec-2021 for product.Batch number: unknown.Sample status: not available.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.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.Final investigation complete date was 10-jan-2022.No safety issues were indicated in this review.Additional information was received on 10-jan-2022 from the quality department.Global ptc number and ptc result added.Text amended accordingly.Upon internal review on 26-sep-2022, case: (b)(4) (to be deleted) was identified to be duplicate of case: (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in current case: clinical course updated and 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: 13098006
• MDR Text Key: 288091185
• Report Number: 2246315-2021-00184
• 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: Foreign,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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): Disability
• Patient Sex: Female