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

Lot Number UNKNOWN

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

Patient Problems Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Greenish yellow in color sample of the fluid drained from the injection area after the first injection [arthrocentesis].Swelling in the injection area after both applications [injection site joint swelling].Discomfort in the injection area after both applications [injection site joint discomfort].Greenish yellow in color sample of the fluid drained from the injection area after the first injection [synovial fluid colour].Received synvisc for swelling in knee via subcutaneous route [drug use via unapproved administration route].Case narrative: initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves a (b)(6) years old male patient who had greenish yellow in color sample of the fluid drained from the injection area after the first injection, swelling in the injection area after both applications, discomfort in the injection area after both applications and received synvisc for swelling in knee via subcutaneous route 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 (b)(6) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength: 8 mg/ml) at the dose of 2 ml via subcutaneous route (product use issue) (batch number, indication: unknown).On the unknown of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling and discomfort in the injection area (injection site joint swelling) (injection site joint discomfort) (medically significant) (intervention required) after both applications doctor drained fluid from the injection area after the first injection caller noted that the fluid was greenish yellow in color sample of the fluid was sent to the lab for testing (aspiration joint) (synovial fluid analysis) (medically significant) (intervention required).Action taken: not applicable for received synvisc for swelling in knee via subcutaneous route; unknown for rest all the events.Corrective treatment: fluid withdrawn for injection site joint swelling; not reported for rest all the events.Outcome: unknown for received synvisc for swelling in knee via subcutaneous route, greenish yellow in color sample of the fluid drained from the injection area after the first injection; recovering for rest both the events.

Event Description

Greenish yellow in color sample of the fluid drained from the injection area after the first injection [arthrocentesis] swelling in the injection area after both applications [injection site joint swelling] discomfort in the injection area after both applications [injection site joint discomfort] knee became edematous [edema knees] drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals [synovial fluid crystal present] greenish yellow in color sample of the fluid drained from the injection area after the first injection [synovial fluid colour] received synvisc for swelling in knee via subcutaneous route [drug use via unapproved administration route] case narrative: initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves a 60 years old male patient who had greenish yellow in color sample of the fluid drained from the injection area after the first injection, swelling in the injection area after both applications, discomfort in the injection area after both applications and received synvisc for swelling in knee via subcutaneous route, drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals, knee became edematous 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 (b)(6) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength: 8 mg/ml) at the dose of 2 ml via subcutaneous route (product use issue) (batch number, indication: unknown).On the unknown of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling and discomfort in the injection area (injection site joint swelling) (injection site joint discomfort) (medically significant) (intervention required) after both applications doctor drained fluid from the injection area after the first injection caller noted that the fluid was greenish yellow in color sample of the fluid was sent to the lab for testing (aspiration joint) (synovial fluid analysis) (medically significant) (intervention required).When the patient had their first injection, their knee became edematous (oedema peripheral) and the doctor drained fluid which demonstrated one part calcium and 1 part pyrophosphate crystals (synovial fluid crystal present).Action taken: not applicable for received synvisc for swelling in knee via subcutaneous route; no action taken for synovial fluid analysis, synovial crystal present; oedema peripheral; unknown for rest all the events.Corrective treatment: fluid withdrawn for injection site joint swelling; not reported for rest all the events.Outcome: unknown for received synvisc for swelling in knee via subcutaneous route, greenish yellow in color sample of the fluid drained from the injection area after the first injection; recovering for rest both the events.A product technical complaint was initiated for synvisc (lot number unknown) with global ptc number 100143283.Additional information was received on 20-jul-2021 from the physician.Events added for drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals, knee became edematous.Action taken updated.Lab added.Clinical course was updated.Text amended accordingly.

Event Description

Greenish yellow in color sample of the fluid drained from the injection area after the first injection [arthrocentesis].Swelling in the injection area after both applications [injection site joint swelling].Discomfort in the injection area after both applications [injection site joint discomfort].Knee became edematous [edema knees].Drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals [synovial fluid crystal present].Greenish yellow in color sample of the fluid drained from the injection area after the first injection [synovial fluid colour].Received synvisc for swelling in knee via subcutaneous route [drug use via unapproved administration route].Case narrative: initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves a 60 years old male patient who had greenish yellow in color sample of the fluid drained from the injection area after the first injection, swelling in the injection area after both applications, discomfort in the injection area after both applications and received synvisc for swelling in knee via subcutaneous route, drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals, knee became edematous 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 (b)(6) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 8 mg/ml) at the dose of 2 ml (16 mg/ 2ml) and frequency: 2 via subcutaneous route for swelling in knee (product use issue) (batch number: unknown).On the unknown of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling and discomfort in the injection area (injection site joint swelling) (injection site joint discomfort) (medically significant) (intervention required) after both applications doctor drained fluid from the injection area after the first injection caller noted that the fluid was greenish yellow in color sample of the fluid was sent to the lab for testing (aspiration joint) (synovial fluid analysis) (medically significant) (intervention required).When the patient had their first injection, their knee became edematous (oedema peripheral) and the doctor drained fluid which demonstrated one part calcium and 1 part pyrophosphate crystals (synovial fluid crystal present).Action taken: not applicable for received synvisc for swelling in knee via subcutaneous route; no action taken for synovial fluid analysis, synovial crystal present; oedema peripheral; unknown for rest all the events.Corrective treatment: fluid withdrawn for injection site joint swelling; not reported for rest all the events.Outcome: unknown for received synvisc for swelling in knee via subcutaneous route, greenish yellow in color sample of the fluid drained from the injection area after the first injection; recovering for rest both the events.A product technical complaint (ptc) was initiated on 20-jul-2021 for synvisc (lot number unknown) with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is 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.Sanofi will continue to monitor complaints to determine if a capa was required.Final investigation was completed on 28-jul-2021 summarized as no assessment possible.Additional information was received on 20-jul-2021 from the physician.Events added for drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals, knee became edematous.Action taken updated.Lab added.Clinical course was updated.Text amended accordingly.Additional information was received on 22-jul-2021 from the non-healthcare professional.Suspect dose details updated.Formulation updated.Text amended accordingly.Additional information was received on 28-jul-2021 from other healthcare professional.Formulation and strength updated.Ptc results received and processed.

Event Description

Knee became edematous [edema knees] greenish yellow in color sample of the fluid drained from the injection area after the first injection [arthrocentesis] swelling in the injection area after both applications [injection site joint swelling] discomfort in the injection area after both applications [injection site joint discomfort] drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals [synovial fluid crystal present] greenish yellow in color sample of the fluid drained from the injection area after the first injection [synovial fluid colour] received synvisc for swelling in knee via subcutaneous route [drug use via unapproved administration route] case narrative: initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves a 60 years old male patient who had greenish yellow in color sample of the fluid drained from the injection area after the first injection, swelling in the injection area after both applications, discomfort in the injection area after both applications and received synvisc for swelling in knee via subcutaneous route, drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals, knee became edematous 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 (b)(6) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 8 mg/ml) at the dose of 2 ml (16 mg/ 2ml) and frequency: 2 via subcutaneous route for swelling in knee (product use issue) (batch number: unknown).On the unknown of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling and discomfort in the injection area (injection site joint swelling) (injection site joint discomfort) (medically significant) (intervention required) after both applications doctor drained fluid from the injection area after the first injection caller noted that the fluid was greenish yellow in color sample of the fluid was sent to the lab for testing (aspiration joint) (synovial fluid analysis) (medically significant) (intervention required).When the patient had their first injection, their knee became edematous (oedema peripheral) and the doctor drained fluid which demonstrated one part calcium and 1 part pyrophosphate crystals (synovial fluid crystal present).Action taken: not applicable for received synvisc for swelling in knee via subcutaneous route; no action taken for synovial fluid analysis, synovial crystal present; oedema peripheral; unknown for rest all the events.Corrective treatment: fluid withdrawn for injection site joint swelling; not reported for rest all the events.Outcome: unknown for received synvisc for swelling in knee via subcutaneous route, greenish yellow in color sample of the fluid drained from the injection area after the first injection; recovering for rest both the events.A product technical complaint (ptc) was initiated on 20-jul-2021 for synvisc (lot number unknown) with global ptc number (b)(4) the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is 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.Sanofi will continue to monitor complaints to determine if a capa was required.Final investigation was completed on 28-jul-2021 summarized as no assessment possible.Additional information was received on 20-jul-2021 from the physician.Events added for drained fluid was greenish/yellow in color and sent to the lab for analysis; the results demonstrated one part calcium and 1 part pyrophosphate crystals, knee became edematous.Action taken updated.Lab added.Clinical course was updated.Text amended accordingly.Additional information was received on 22-jul-2021 from the non-healthcare professional.Suspect dose details updated.Formulation updated.Text amended accordingly.Additional information was received on 28-jul-2021 from other healthcare professional.Formulation and strength updated.Ptc results received and processed.

• 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: 12217284
• MDR Text Key: 263546071
• Report Number: 2246315-2021-00128
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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
• Patient Sex: Male