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

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

Patient Problems Pain (1994); Burning Sensation (2146); No Code Available (3191)

Event Date 04/26/2012

Event Type  Injury  

Event Description

Burning, stinging and pain in thigh and lower leg muscle of right leg/pain in the lower leg and upper thigh of right leg/in pain 24 hrs a day [burning leg] burning, stinging and pain in thigh and lower leg muscle of right leg/pain in the lower leg and upper thigh of right leg/in pain 24 hrs a day [pain in leg].Since that day life has been pure hell/have no life/ invalid/have poisoned [feeling abnormal] ([off label use of device]).Case narrative: the case is linked to (b)(4) (cluster).Initial information received on (b)(6) 2020 regarding an unsolicited valid serious case from health authorities of united states under reference mw5097908 via patient.This case involves a patient of unknown demographics who experienced burning, stinging and pain in thigh and lower leg muscle of right leg/pain in the lower leg and upper thigh of right leg/in pain 24 hrs a day and since that day life has been pure hell/have no life/ invalid/have been poisoned, while he/she was treated 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) and family history were not provided.No information regarding concomitant medication was provided on (b)(6) 2012, the patient received treatment with hylan g-f 20, sodium hyaluronate injection in right knee by orthopedic surgeon at a dose of 48mm once via intra articular route (batch number - unknown) that was supposed to replace lack of cartilage in right knee due to severe osteoporosis (off label use of device).On (b)(6) 2012, within few hours after same day latency, patient started experiencing burning, stinging and pain in thigh and lower leg muscle of right leg (burning sensation an pain in extremity; seriousness criteria: medically significant and was leading to disability; permanent damage) for which treatment included nsaids (non-steroidal anti-inflammatory drugs) like acetaminophen and ibuprofen.Patient reported that since this day, life had been pure hell, felt betrayed by orthopedic surgeon.The patient started feeling that he/she had been poisoned (feeling abnormal) (seriousness criteria: medically significant and was leading to disability; permanent damage).The patient was in pain 24 hours a day and burning sensation and pain in extremity was only mildly relieved for short periods only by nsaids.Patient had burning and stinging pain in upper thigh and lower right leg that never went away.Patient was taking too many nsaids (non-steroidal anti-inflammatory drugs), as trying to get relief and to take the edge of the pain.The patient was prescribed with gabapentin as well by primary doctor which also did not help very much with the pain.Patient then called medical group care and was told that they had heard about side effects of hylan g-f 20, sodium hyaluronate injection and it basically had to wear out of body which would probably take at least 3 months.Patient was reading that hylan g-f 20, sodium hyaluronate contains formaldehyde and divinyl sulfone in permissible levels regarding which patients were not informed.Patient was wondering how this drug was approved by fda (food and drug administration) as it would be injected into body and one cannot stop taking it as a pill.Patient again reported having pure hell and no life; was feeling invalid and did not know how long it would take to be flushed out of system.Patients doctor recommended knee replacement and patient felt that he/she was forced to try this injection.Action taken: not applicable for all events.The patient was treated with ibuprofen, gabapentin and acetaminophen for burning sensation and pain in extremity; not reported for other event the patient outcome is reported as unknown for feeling abnormal; recovering for rest events.A product technical complaint (ptc) was initiated on (b)(6) 2020 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 had 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: (b)(6) 2020.Additional information was received on (b)(6) 2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 11086065
• MDR Text Key: 229833963
• Report Number: 2246315-2020-00184
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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; Disability