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

Lot Number BRSL015

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 Date 01/01/2021

Event Type  Injury  

Event Description

Legs were beginning to not hold me up [weight bearing difficulty].Moderate to severe neuropathy [neuropathy].Withdrew fluid [knee effusion].Felt strange [feeling strange].Severe pain all over my body [general body pain].Case narrative: initial information received from (b)(6) on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.This case involves (b)(6) female patient who experienced moderate to severe neuropathy, had fluid withdrawn, legs were beginning to not hold her up, felt strange and had severe pain all over my body while being treated with the use of medical device hylan g-f 20,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.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate solution for injection at a dose of 6 ml once (lot - unknown) for osteoarthritis.By the time patient left the doctor's office, her legs were beginning to not hold her up (weight bearing difficulty; onset: (b)(6) 2021; latency: same day; seriousness: intervention required) felt strange (feeling abnormal; onset: (b)(6) 2021; latency: same day) and had severe pain all over body (pain; onset: (b)(6) 2021; latency: same day).The patient went to a doc-in-the-box (urgent care) 3 times and the emergency room (er) 2 times.The doctor who did the injections withdrew fluid (joint effusion; latency: unknown; seriousness: medically significant and intervention required) and injected cortisone on an unknown date in 2021.Now the patient was under treatment by a rheumatologist and was on more medications.A neurologist did 'muscle stim' testing and determined that had moderate to severe neuropathy as a result of the injections (neuropathy peripheral; onset: 2021; latency: unknown; seriousness: medically significant).Action taken: not applicable.The patient was treated with cortisone acetate for weight bearing difficulty; fluid was withdrawn for joint effusion; no other treatment reported.At time of reporting, the outcome was not recovered / not resolved for all events.

Event Description

Legs were beginning to not hold me up [weight bearing difficulty].Moderate to severe neuropathy [neuropathy].Withdrew fluid [knee effusion].Felt strange [feeling strange].Severe pain all over my body [general body pain].Case narrative: initial information received from united states on 09-dec-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.This case involves 78 years old female patient who experienced moderate to severe neuropathy, had fluid withdrawn, legs were beginning to not hold her up, felt strange and had severe pain all over my body while being 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.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate solution for injection at a dose of 6 ml once (lot - brsl015) for osteoarthritis.By the time patient left the doctor's office, her legs were beginning to not hold her up (weight bearing difficulty; onset: (b)(6) 2021; latency: same day; seriousness: intervention required) felt strange (feeling abnormal; onset: (b)(6) 2021; latency: same day) and had severe pain all over body (pain; onset: (b)(6) 2021; latency: same day).The patient went to a doc-in-the-box (urgent care) 3 times and the emergency room (er) 2 times.The doctor who did the injections withdrew fluid (joint effusion; latency: unknown; seriousness: medically significant and intervention required) and injected cortisone on an unknown date in 2021.Now the patient was under treatment by a rheumatologist and was on more medications.A neurologist did 'muscle stim' testing and determined that had moderate to severe neuropathy as a result of the injections (neuropathy peripheral; onset: 2021; latency: unknown; seriousness: medically significant).Action taken: not applicable.The patient was treated with cortisone acetate for weight bearing difficulty; fluid was withdrawn for joint effusion; no other treatment reported.At time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated for synvisc one (lot number: brsl015) and results were pending for the same.Additional information was received on 15-dec-2021 from the quality department.Lot number added.Text amended accordingly.

Event Description

Legs were beginning to not hold me up [weight bearing difficulty].Moderate to severe neuropathy [neuropathy].Withdrew fluid [knee effusion].Felt strange [feeling strange].Severe pain all over my body [general body pain].Case narrative: initial information received from united states on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.This case involves 78 years old female patient who experienced moderate to severe neuropathy, had fluid withdrawn, legs were beginning to not hold her up, felt strange and had severe pain all over my body while being 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.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6ml) at a dose of 6 ml once (lot - brsl015; expiry date: 31-mar-2024) for osteoarthritis.By the time patient left the doctor's office, her legs were beginning to not hold her up (weight bearing difficulty; onset: (b)(6) 2021; latency: same day; seriousness: intervention required) felt strange (feeling abnormal; onset: (b)(6) 2021; latency: same day) and had severe pain all over body (pain; onset: (b)(6) 2021; latency: same day).The patient went to a doc-in-the-box (urgent care) 3 times and the emergency room (er) 2 times.The doctor who did the injections withdrew fluid (joint effusion; latency: unknown; seriousness: medically significant and intervention required) and injected cortisone on an unknown date in 2021.Now the patient was under treatment by a rheumatologist and was on more medications.A neurologist did 'muscle stim' testing and determined that had moderate to severe neuropathy as a result of the injections (neuropathy peripheral; onset: 2021; latency: unknown; seriousness: medically significant).Action taken: not applicable.The patient was treated with cortisone acetate for weight bearing difficulty; fluid was withdrawn for joint effusion; no other treatment reported.At time of reporting, the outcome was not recovered / not resolved for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number: brsl015.Sample status: not available.Device not returned.The production and quality control documentation for lot brsl015, expiration date mar-2024 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot brsl015 no capa (corrective and preventive action) is required.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.File for lot# brsl015: (2) tip breakage, (1) bubble in the syringe, (1) broken syringe and (3) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: 03-jan-2022 with summary code as no assessment possible.Additional information was received on 15-dec-2021 from the quality department.Lot number added.Text amended accordingly.Additional information was received on 03-jan-2022 from healthcare professional.Global ptc result, form and strength added.Text was 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: 13018085
• MDR Text Key: 288583208
• Report Number: 2246315-2021-00181
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2022

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?: No
• Device Expiration Date: 03/31/2024
• Device Lot Number: BRSL015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2021; 01/10/2022
• 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
• Patient Sex: Female