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

Lot Number UNKNOWN

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

Patient Problem Anaphylactic Shock (1703)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 09-apr-2021: this case concerns a patient who was on treatment with synvisc one and reported to have anaphylactic shock.The information in the case is very limited.Therefore, the causality with the drug cannot be established.However, patient had history of egg allergy and synvisc one is contraindicated for patient with known avian protein hypersensitivity, so this could be a cofounding factor for the occurrence of event.Further, detailed information regarding other medications and clinical course of the event would aid in comprehensive assessment of the case.

Event Description

Anaphylactic reaction after injection in knee/anaphylactic shock [anaphylactic shock] ([movements reduced], [passed out], [swelling of tongue], [contraindicated device used]) case narrative: initial information received from united states on 07-apr-2021 regarding an unsolicited valid serious case received from patient and her spouse.This case involves a (b)(6) years old female patient who experienced anaphylactic reaction after injection in knee/anaphylactic shock, while she was treated with 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.At the time of the event, the patient had ongoing egg allergy.On (b)(6) 2019, the patient had hylan g-f 20, sodium hyaluronate solution for injection at an unknown dose, once via unknown route (with an unknown batch number) for osteoarthritis and knee pain.Patient had anaphylactic reaction after injection in knee (anaphylactic shock, onset: (b)(6) 2019, latency: same day).Patient had an egg allergy and hcp (healthcare professional) did not ask if she had this allergy (contraindicated device used).Within 24 hours she "passed out", dropped to the floor on her back and could not move, had tongue swelling (loss of consciousness, swollen tongue, hypokinesia; onset: (b)(6) 2019, latency: same day).This lasted about 15 seconds.She went to ed (emergency department) for anaphylactic shock.She did state her knee felt better after the injection.Events were assessed as medically significant.Action taken: not applicable.It was not reported if the patient received a corrective treatment.Outcome: recovered for loss of consciousness, swollen tongue, hypokinesia, unknown for rest of the events.A product technical complaint was initiated and results were pending for the same.

Event Description

Anaphylactic reaction after injection in knee/anaphylactic shock [anaphylactic shock] ([movements reduced], [passed out], [swelling of tongue], [contraindicated device used]) case narrative: initial information was received from united states on (b)(6) 2021 regarding an unsolicited valid serious case from patient and her spouse.This case involves a 78 years old female patient who experienced anaphylactic reaction after injection in knee/anaphylactic shock, while she was treated with 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.At the time of the event, the patient had ongoing egg allergy.On (b)(6) 2019, the patient had hylan g-f 20, sodium hyaluronate solution for injection at an unknown dose, once via unknown route (with an unknown batch number) for osteoarthritis and knee pain.Patient had anaphylactic reaction after injection in knee (anaphylactic shock, seriousness criteria: medically significant and intervention required, onset: (b)(6)2019, latency: same day).Patient had an egg allergy and hcp (healthcare professional) did not ask if she had this allergy (contraindicated device used).Within 24 hours she "passed out", dropped to the floor on her back and could not move, had tongue swelling (loss of consciousness, swollen tongue, hypokinesia; onset: (b)(6)2019, latency: same day).This lasted about 15 seconds.She went to ed (emergency department) for anaphylactic shock.She did state her knee felt better after the injection.Events were assessed as medically significant.Action taken: not applicable.It was not reported if the patient received a corrective treatment.Outcome: recovered for loss of consciousness, swollen tongue, hypokinesia, unknown for rest of the events3 a product technical complaint (ptc) was initiated on (b)(6)2021 for synvisc one for unknown batch number and global ptc number: 100116529.The product lot number was not provided; therefore, a batch record review was not possible.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 ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: (b)(6) 2021 additional information was received on (b)(6)2021 from other healthcare professional.Gptc (expanded form not specified) number was added.Additional information was received on (b)(6)2021 from healthcare professional.Investigational results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11641069
• MDR Text Key: 244972420
• Report Number: 2246315-2021-00088
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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 Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention