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 Rash (2033)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 23-oct-2020: this case involves (b)(6) years old female patient who started treatment with (b)(4), sodium hyaluronate and experienced skin rash at first at knee area afterwards thigh area too for which patient was administered locally with cortisone ointment.Based on the information available, the casual relationship between event and suspect cannot be denied.Furthermore, information regarding family history, detailed diagnosis of the events, reported concomitant medications, lifestyle history, more relevant medical history, and concurrent conditions will aid in comprehensive assessment of this case.

Event Description

Skin rash at first at knee area afterwards thigh area too [skin rash].Case narrative: initial information received from (b)(6) on 23-oct-2020 regarding an unsolicited valid serious case received from a physician via sales representative.This case involves a (b)(6) year- old female patient who experienced skin rash at first at knee area afterwards thigh area too, while she was treated with the use of medical device (b)(4), sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s), and family history were not provided.Patient had no medical history of pathologies, allergy, and previous hypersensitivity reactions.On an unknown date, the patient started treatment with (b)(4), sodium hyaluronate (first treatment) at knee joint (formulation, dose, route, frequency: unknown) for unknown indication.On an unknown date, two days after the application of hylan g-f 20, sodium hyaluronate, patient experienced skin rash at first at knee area afterwards at thigh area too (seriousness criteria: intervention required) (rash).Then, the patient was administered locally with cortisone ointment and antihistaminic therapy, afterwards on an unknown date, got fully recovered within few days.Action taken: unknown.The patient was administered locally with cortisone ointment and antihistaminic therapy for rash.The patient outcome is reported as recovered / resolved.

Event Description

Skin rash at first at knee area afterwards thigh area too [skin rash].Case narrative: initial information received from italy on 23-oct-2020 regarding an unsolicited valid serious case received from a physician via sales representative.This case involves a 50 years old female patient who experienced skin rash at first at knee area afterwards thigh area too, while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.Patient had no medical history of pathologies, allergy and previous hypersensitivity reactions.On an unknown date, the patient started treatment with hylan g-f 20, sodium hyaluronate (first treatment) at knee joint (formulation, dose, route, frequency: unknown) for unknown indication.On an unknown date, two days after the application of hylan g-f 20, sodium hyaluronate, patient experienced skin rash at first at knee area afterwards at thigh area too (rash) (seriousness criteria: intervention required).Then, the patient was administered locally with cortisone ointment and antihistaminic therapy, afterwards on an unknown date, got fully recovered within few days.Action taken: unknown.The patient was administered locally with cortisone ointment and antihistaminic therapy for rash.The patient outcome is reported as recovered / resolved.A product technical complaint (ptc) was initiated on 23-oct-2020 for synvisc for unknown batch number and global ptc number: (b)(4).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 are 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: 02-nov-2020.Additional information received on 02-nov-2020 from healthcare professional.Global ptc number and its investigational results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10753453
• MDR Text Key: 214327755
• Report Number: 2246315-2020-00151
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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): Required Intervention
• Patient Age: 50 YR