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

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

Patient Problems Neuropathy (1983); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Diabetes ii [type 2 diabetes mellitus].Neuropathy [neuropathy] ([burning sensation], [blood flow sensation], [numbness]) swelling in that left leg [unilateral leg swelling], swelling/ swelling in the ankle area [joint swelling].Case narrative: this case is cross referenced with case: (b)(4)(cluster).Initial information received on 01-jun-2016 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves adult male patient who experienced neuropathy, diabetes ii, swelling in that left leg and swelling/ swelling in the ankle area with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular synvisc injection (dose, frequency, indication, batch/lot number and expiration date: not provided).On an unknown date, after unknown latency, the patient experienced swelling (joint swelling).On an unknown date after unknown latency patient had an allergy response of swelling in the left leg (peripheral swelling), left leg in the thigh area started a sensation of running fluid (sensation of blood flow), swelling in the ankle area (joint swelling), numbness (hypoaesthesia), burning sensation that then proceeded to the right leg (burning sensation).The symptoms were giving the more sensation of neuropathy (neuropathy peripheral; onset and latency: unknown), neurologist did electromyogram (emg) test and verified the diagnosis.The events of neuropathy peripheral, sensation of blood flow, burning sensation and hypoaesthesia were considered medically significant.Patient reported that since an unknown date after unknown latency patient had diabetes ii (type 2 diabetes mellitus; seriousness: medically significant) which was 6.5 -6.9 (unspecified test).Patient believed that others had had this response so requested for suggestions for care.Relevant laboratory test results included: electromyogram - on an unknown date: neuropathy.Glycosylated haemoglobin - on an unknown date: 6.5 -6.9.Action taken: unknown for all events.Corrective treatment: not reported for all events.Outcome: unknown for all events.Product technical complaint (ptc) was initiated with global ptc number 42954 on 01-jun-2016 for product.Batch number; unknown device not returned.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 was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Final investigation complete date: 14-jun-2016.Additional information was received on 14-jun-2016: global ptc number and ptc results were added.Text was amended accordingly.Additional information received on 16-jul-2021 from the patient.Case was updated to serious.Events of neuropathy peripheral, sensation of blood flow, burning sensation, type 2 diabetes mellitus, peripheral swelling and hypoaesthesia were added.Verbatim of swelling was updated to swelling/ swelling in the ankle area.Clinical course updated and text amended.

• 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: 12217162
• MDR Text Key: 266402009
• Report Number: 2246315-2021-00126
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2021
• 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