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

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

Patient Problems Fever (1858); Rash (2033); Swelling (2091); Phototoxicity (2165); Chills (2191); Reaction, Injection Site (2442)

Event Date 06/01/2020

Event Type  Injury  

Event Description

Phototoxic drug eruption [phototoxicity] ([rash aggravated], [fever], [chills], [injection site rash], [swelling]).Case narrative: initial information received on 18-dec-2020 regarding an unsolicited valid serious case received from a other health professional.This case involves a (b)(6) years old male patient who experienced phototoxic drug eruption, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, vaccination(s) and family history were not provided.Patient had received hylan g-f 20, sodium hyaluronate in his right knee thrice.On (b)(6) 2020, the patient had fourth injection of hylan g-f 20, sodium hyaluronate, solution for injection once in right knee (dose, route, lot - unknown) for osteoarthritis.Information on batch number was requested.On an unknown date in (b)(6) 2020, after unknown latency, patient experienced rash all over his body (rash), fever (pyrexia), chills, swelling and injection site rash.Each time the patient received injection, he had a progressively worsening rash (rash).On (b)(6) 2020, patient received skin biopsy that showed a photo toxic drug eruption.The patient was treated with steroids and the symptoms resolved.First time product used: no.Action taken: not applicable.Corrective treatment: steroids.Outcome: recovered.A product technical complaint was initiated and results were pending for the same.

Event Description

Phototoxic drug eruption [phototoxicity] ([rash aggravated], [fever], [chills], [injection site rash], [swelling]).Case narrative: initial information received on 18-dec-2020 regarding an unsolicited valid serious case received from a other health professional.The case is linked to (b)(4)(multiple devices for same patient).This case involves a 71 years old male patient who experienced phototoxic drug eruption, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, vaccination(s) and family history were not provided.Patient had received hylan g-f 20, sodium hyaluronate in his right knee thrice.On (b)(6)2020, the patient had fourth injection of hylan g-f 20, sodium hyaluronate, solution for injection once in right knee (dose, route, lot - unknown) for osteoarthritis.Information on batch number was requested.On an unknown date in (b)(6)2020, after unknown latency, patient experienced rash all over his body (rash), fever (pyrexia), chills, swelling and injection site rash.Each time the patient received injection, he had a progressively worsening rash (rash).On (b)(6)2020, patient received skin biopsy that showed a photo toxic drug eruption (photosensitivity reaction, latency: unknown).The patient was treated with steroids and the symptoms resolved.Event was assessed as serious due to required intervention.Product was not used for the first time.Action taken: not applicable.Corrective treatment: steroids.Outcome: recovered.A product technical complaint (ptc) was initiated on 18-dec-2020 for synvisc one.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 06-jan-2021.Follow up information was received on 18-dec-2020 from healthcare professional.Global ptc number was added.Text amended accordingly.Follow up information was received on 18-dec-2020 from healthcare professional.Global ptc number was updated.Text amended accordingly.Additional information was received on 06-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.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: 11073507
• MDR Text Key: 228403740
• Report Number: 2246315-2020-00178
• 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
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention