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

Lot Number UNKNOWN

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

Patient Problems Itching Sensation (1943); Hot Flashes/Flushes (2153)

Event Date 02/19/1999

Event Type  Injury  

Event Description

Scratchy eyes [abnormal sensation in eye] myalgias [myalgia].Flushing [flushing] case narrative: this case is submitted following an incorrect worldwide id in case id ((b)(4)) which will be deleted.This report contains no new information.This case is linked to case (b)(4)(multiple devices).Initial information received on 08-jan-2021 regarding an unsolicited valid serious case from physician via health authorities of united states under reference mw5097839.This case involves adult patient (gender unknown) who was given hylan g-f 20, sodium hyaluronate (synvisc) and experienced scratchy eyes, flushing, myalgias.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate intra-articular injection (dose, frequency, indication, lot - unknown).Information on the batch number was requested.On (b)(6) 1999, (following injection of knees with hylan g-f 20, sodium hyaluronate), after unknown latency, patient had flushing, scratchy eyes (abnormal sensation in eye), myalgias (myalgia).Events of flushing, scratchy eyes, myalgia were assessed as medically significant.Action taken: unknown for all the events.It was not reported if the patient received a corrective treatment.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc; 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 the lack of information provided, no capa (corrective and preventive action) is required.It is 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 (non-conformance) 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 has not indicated any safety issue.Sanofi will continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa is required.Final investigation was completed on 21-jan-2021.Additional information was received on 08-jan-2021 from other healthcare professional.Global ptc number was added.Additional information was received on 08-jan-2021 from a physician.Event- given hylan g-f 20, sodium hyaluronate (synvisc) via intraarticular route for serious injury (product use in unapproved indication) was deleted.Indication was updated from serious injury to unknown.Clinical course was updated.Text was amended accordingly.Additional information was received on 21-jan-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

• Brand Name: SYNVISC
• 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: 11974135
• MDR Text Key: 255657115
• Report Number: 2246315-2018-00884
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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
• 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): Other; Required Intervention