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 Irritation (1941); Synovitis (2094); Hot Flashes/Flushes (2153); Myalgia (2238)

Event Date 03/21/1999

Event Type  Injury  

Event Description

Scratchy eyes [irritation of eyes], flushing [flushing], myalgias [myalgia], synovitis of (l) knee "joint results, and referenced here" biomatrix [synovitis of knee] ([product use in unapproved indication]).Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from physician via health authorities of united states under reference mw5097842.This case involves adult patient of unknown gender who experienced scratchy eyes, flushing, myalgias and synovitis of (l) knee "joint results, and referenced here" biomatrix, while he/she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included diclofenac (voltaren); and famotidine (pepcid 20 rnd) and vitamin on an unknown date, the patient started using intra-articular injection of hylan g-f 20, sodium hyaluronate (dose, frequency, lot - unknown) for serious injury (product use in unapproved indication).There will be no information available on the batch number for this case.On an unknown date, after unknown latency, patient had flushing, scratchy eyes (eye irritation), myalgias (myalgia) following injection of knees with hylan g-f 20, sodium hyaluronate.On (b)(6) 1999, after unknown latency, patient had synovitis of (l) knee "joint results and referenced here" biomatrix (synovitis).All events were assessed as serious as intervention was required.Action taken: unknown for all events.It was not reported if the patient received a corrective treatment.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc one 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 were 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: 22-jan-2021.Follow up received on 08-jan-2021 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 22-jan-2021 from healthcare professional.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
• 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: 11257832
• MDR Text Key: 233159645
• Report Number: 2246315-2021-00059
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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): Required Intervention