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

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

Patient Problems Injury (2348); Disability (2371); Ambulation Difficulties (2544); No Code Available (3191); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Was incapacitated from attending to his usual employment and vocation and may, in the future, be so incapacitated/ sustained a loss and/or limitation of quality and/or enjoyment of life and/or body member [activities of daily living impaired].Became sore, lame and disabled [disability nos].Was confined to the hospital, bed and home and may, in the future, be so confined [mobility decreased].Caused to sustain and suffer severe and permanent injuries [injury nos].Became sore, lame and disabled [pain nos].Suffered injury to his nervous system [nervous system injury].Suffered mental anguish [anguish].Case narrative: initial information from united states received on (b)(6) 2021 regarding an unsolicited valid serious case received from the patient.This case involves an adult patient who experienced was incapacitated from attending to his usual employment and vocation and may, in the future, be so incapacitated/ sustained a loss and/or limitation of quality and/or enjoyment of life and/or body member, became sore, lame and disabled, caused to sustain and suffer severe and permanent injuries, became sore, lame and disabled, suffered injury to his nervous system, suffered mental anguish and was confined to the hospital, bed and home and may, in the future, be so confined, while he/she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2011, the patient started taking hylan g-f 20, sodium hyaluronate (unknown dose, frequency, route, batch number, indication).On an unknown date after unknown latency patient was incapacitated from attending to his usual employment and vocation and may, in the future, be so incapacitated/ sustained a loss and/or limitation of quality and/or enjoyment of life and/or body member (loss of personal independence in daily activities).This event was leading to disability.On an unknown date after an unknown latency patient developed a serious became sore, lame and disabled (disability), caused to sustain and suffer severe and permanent injuries (injury), became sore, lame and disabled (pain), injury to his nervous system (nervous system injury), suffered mental anguish (anxiety), was confined to the hospital, bed and home and may, in the future, be so confined (mobility decreased).Action taken: unknown for all events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not recovered / not resolved for injury nos; unknown for other events.A product technical complaint was initiated and the results for the same were pending.

Event Description

Was incapacitated from attending to his usual employment and vocation and may, in the future, be so incapacitated/ sustained a loss and/or limitation of quality and/or enjoyment of life and/or body member [activities of daily living impaired].Became sore, lame and disabled [disability nos] was confined to the hospital, bed and home and may, in the future, be so confined [mobility decreased] caused to sustain and suffer severe and permanent injuries [injury nos].Became sore, lame and disabled [pain nos].Suffered injury to his nervous system [nervous system injury].Suffered mental anguish [anguish].Case narrative: initial information from united states received on 14-jan-2021 regarding an unsolicited valid serious case received from the patient.This case involves an adult patient (gender: unknown) who was incapacitated from attending to his usual employment and vocation and may, in the future, be so incapacitated/ sustained a loss and/or limitation of quality and/or enjoyment of life and/or body member, became sore, lame and disabled, caused to sustain and suffer severe and permanent injuries, suffered injury to his nervous system, suffered mental anguish and was confined to the hospital, bed and home and may, in the future, be so confined, while he/she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2011, the patient started taking hylan g-f 20, sodium hyaluronate (unknown dose, frequency, route, batch number, indication).Information on batch number was requested.On an unknown date after unknown latency patient was incapacitated from attending to his usual employment and vocation and may, in the future, was so incapacitated, sustained a loss and/or limitation of quality and/or enjoyment of life and/or body member (loss of personal independence in daily activities).This event was leading to disability.On an unknown date after an unknown latency patient became sore, lame and disabled (pain; disability), caused to sustain and suffer severe and permanent injuries (injury), injury to his nervous system (nervous system injury), suffered mental anguish (anxiety), was confined to the hospital, bed and home and may, in the future, be so confined (mobility decreased).Action taken: unknown for all events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not recovered for injury; unknown for rest of the events.A product technical complaint (ptc) was initiated on 14-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: 02-feb-2021 follow up was received on 14-jan-2021 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 02-feb-29021 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
• MDR Report Key: 11213422
• MDR Text Key: 230768407
• Report Number: 2246315-2021-00030
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability