MAUDE Adverse Event Report: SYNVISC ONE; MOZ

Lot Number UNKNOWN

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Severe reaction from the injection (allergic reaction) [allergic reaction].Case narrative: this case was linked to case (b)(4) (same patient) and (b)(4) (multiple devices, right knee).Initial information received on 10-jan-2020 regarding a solicited valid serious case received from a consumer via call center, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc one.This case involves an adult female patient who experienced severe reaction from the injection (allergic reaction) (latency: unknown), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in left knee at dosage 6 ml, frequency once (indication, batch: unknown).On an unknown date, patient experienced severe reaction from the injection (allergic reaction) (latency: unknown).This event was assessed as serious and led to hospitalization.Patient was asked if she was allergic to chicken feather/shells and would be able to provide details on 14-jan-2020.Action taken: not applicable.Outcome: recovered/resolved.Reporter causality: not reported.Company comment: reportable.

Event Description

Severe reaction from the injection (allergic reaction) [allergic reaction].Case narrative: this case was linked to case (b)(4) (same patient) and (b)(4) (multiple devices, right knee).Initial information received on 10-jan-2020 regarding a solicited valid serious case received from a consumer via call center, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada study title: patient support program involving synvisc one.This case involves an adult female patient who experienced severe reaction from the injection (allergic reaction) (latency: unknown), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in left knee at dosage 6 ml, frequency once (indication, batch: unknown).On an unknown date, patient experienced severe reaction from the injection (allergic reaction) (latency: unknown).This event was assessed as serious and led to hospitalization.Patient was asked if she was allergic to chicken feather/shells and would be able to provide details on 14-jan-2020.Action taken: not applicable.Outcome: recovered/resolved.A product technical complaint (ptc) was initiated on 21-jan-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 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 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 adverse events to determine if a capa was required.Investigation complete date: in process reporter causality: not reported.Company comment: reportable.Additional information was received on 19-feb-2020 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
• MDR Report Key: 9615791
• MDR Text Key: 189992680
• Report Number: 2246315-2020-00011
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention