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 Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Chronic Obstructive Pulmonary Disease (COPD) (2237); No Code Available (3191)

Event Date 07/23/2013

Event Type  Injury  

Event Description

Possible delayed onset allergic reaction to synvisc (right knee) [delayed type hypersensitivity] ([angioedema], [copd exacerbation], [itching]).Case narrative: initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received from nurse via health authorities of united states under reference mw5097912.The case was linked to (b)(4) (multiple devices for same patient: left knee).This case involves an unknown age female patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and experienced possible delayed onset allergic reaction to synvisc (right knee).The patient's past medical history, vaccination(s) and family history were not provided.At the time of the event, the patient had copd (chronic obstructive pulmonary disease), undocumented intolerance to egg products and had previously received hylan g-f 20, sodium hyaluronate (synvisc) without difficulty.Concomitant medication included chronic oral steroids.On an unknown date in 2013, the patient started using intra-articular injection of hylan g-f 20, sodium hyaluronate at the dose of 6 ml once in right knee (lot - unknown) for unknown indication.There would be no information available on the batch number for this case.On (b)(6) 2013, after unknown latency, patient had possible delayed allergic reaction to hylan g-f 20, sodium hyaluronate (type iv hypersensitivity reaction) and patient had itching (pruritus), angioedema which she reported to her pcp (primary care physician).Patient was hospitalized locally and was diagnosed with a copd exacerbation (chronic obstructive pulmonary disease) (onset: (b)(6) 2013).Patient was now on 3l of o2 (oxygen) by nc (nasal cannula) at all times.Event of type iv hypersensitivity reaction and its symptoms assessed as serious due to hospitalization and medically significant.Action taken: not applicable.Corrective treatment: o2.Outcome: unknown.A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one with unknown batch number and global ptc 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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa was required.Final investigation was received on (b)(6) 2020.Follow up was received on (b)(6) 2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on (b)(6) 2020 from other healthcare professional.Ptc results received and processed.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 11086650
• MDR Text Key: 229836564
• Report Number: 2246315-2020-00187
• 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
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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
• 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): Hospitalization; Other; Required Intervention