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 Pain (1994)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from (b)(6).This case is linked to case (b)(4) (same patient).This case involves (b)(6)female patient who experienced pain with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In june 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, strength, indication, batch number and expiry date: unknown).Since 2021 the patient was still in a lot of pain and had been in pain for 5 months.She asked how long the product would last and when would it be reabsorbed.The patient was not taking any other medication but her doctor had prescribed quite a few things for the pain which she no longer took because they did not work: (b)(6).Action taken: unknown the patient was treated with (b)(6) for pain.At time of reporting, the outcome was unknown for the event pain.

Event Description

Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from (b)(6).This case is linked to case (b)(4) (same patient).This case involves (b)(6)female patient who experienced pain with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, strength, indication, batch number and expiry date: unknown).Since 2021 the patient was still in a lot of pain and had been in pain for 5 months.She asked how long the product would last and when would it be reabsorbed.The patient was not taking any other medication but her doctor had prescribed quite a few things for the pain which she no longer took because they did not work: (b)(6).Action taken: unknown the patient was treated with (b)(6) for pain.At time of reporting, the outcome was unknown for the event pain.

Event Description

Pain [pain].Case narrative: initial information received on 03-nov-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from france.This case is linked to case (b)(4).(same patient).This case involves 72 years old female patient who experienced pain with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, strength, indication, batch number and expiry date: unknown).Since 2021 the patient was still in a lot of pain and had been in pain for 5 months.She asked how long the product would last and when would it be reabsorbed.The patient was not taking any other medication but her doctor had prescribed quite a few things for the pain which she no longer took because they did not work: codeine and cortisone.Action taken: unknown.The patient was treated with codeine and cortisone for pain.At time of reporting, the outcome was unknown for the event pain.Based on information previously received, the preliminary comment has been added and corrective action has been amended in the eu/ ca device form.

Manufacturer Narrative

Sanofi company comment dated 15-nov-2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but still had pain and received codeine and cortisone for the same.Based on the lack of information, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but still had pain and received codeine and cortisone for the same.Based on the lack of information, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Pain [pain].Case narrative: initial information received on 03-nov-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from france.This case is linked to (b)(4) (same patient).This case involves 72 years old female patient who experienced pain with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, strength, indication, batch number and expiry date: unknown).Since 2021 the patient was still in a lot of pain and had been in pain for 5 months.She asked how long the product would last and when would it be reabsorbed.The patient was not taking any other medication but her doctor had prescribed quite a few things for the pain which she no longer took because they did not work: codeine and cortisone.Action taken: unknown.The patient was treated with codeine and cortisone for pain.At time of reporting, the outcome was unknown for the event pain.A product technical complaint (ptc) was initiated on 03-nov-2021 for synvisc.Batch number: unknown; comet compliant id number: (b)(4).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 23-feb-2022.No safety issues were indicated in this review.Based on information previously received, the preliminary comment has been added and corrective action has been amended in the eu/ ca device form.Additional information was received on 23-feb-2022 from the quality department.Global ptc number and ptc results added.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but still had pain and received codeine and cortisone for the same.Based on the lack of information, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Pain [pain].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from france.This case is linked to case (b)(4) (same patient).This case involves 72 years old female patient who experienced pain with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, strength, indication, batch number and expiry date: unknown).Since 2021 the patient was still in a lot of pain and had been in pain for 5 months.She asked how long the product would last and when would it be reabsorbed.The patient was not taking any other medication but her doctor had prescribed quite a few things for the pain which she no longer took because they did not work: codeine and cortisone.Action taken: unknown.The patient was treated with codeine and cortisone for pain.At time of reporting, the outcome was unknown for the event pain.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc.Batch number: unknown; comet compliant id number: (b)(4).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 23-feb-2022.No safety issues were indicated in this review.Based on information previously received, the preliminary comment has been added and corrective action has been amended in the eu/ ca device form.Additional information was received on 23-feb-2022 from the quality department.Global ptc number and ptc results added.Text amended accordingly.Based on the information received on 23-feb-2022.The mir form is updated.Text amended accordingly.

Event Description

Pain case narrative: initial information received on 03-nov-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from france.This case is linked to case (b)(6) (same patient).This case involves 72 years old female patient who experienced pain with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, strength, indication, batch number and expiry date: unknown).Since 2021 the patient was still in a lot of pain and had been in pain for 5 months.She asked how long the product would last and when would it be reabsorbed.The patient was not taking any other medication but her doctor had prescribed quite a few things for the pain which she no longer took because they did not work: codeine and cortisone.Action taken: unknown.The patient was treated with codeine and cortisone for pain.At time of reporting, the outcome was unknown for the event pain.A product technical complaint (ptc) was initiated on 03-nov-2021 for synvisc.Batch number: unknown; comet compliant id number: (b)(4).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 23-feb-2022.No safety issues were indicated in this review.Based on information previously received, the preliminary comment has been added and corrective action has been amended in the eu/ca device form.Additional information was received on 23-feb-2022 from the quality department.Global ptc number and ptc results added.Text amended accordingly.Based on the information received on 23-feb-2022.The mir form is updated.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but still had pain and received codeine and cortisone for the same.Based on the lack of information, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

• 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: 12814414
• MDR Text Key: 285177011
• Report Number: 2246315-2021-00172
• 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,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• 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
• 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
• Patient Age: 72 YR
• Patient Sex: Female