MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

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

Patient Problems Cellulitis (1768); Arthralgia (2355); Joint Swelling (2356)

Event Date 11/14/2017

Event Type  Injury  

Event Description

This unsolicited case from united states was received on (b)(4) 2017 from nurse.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and on the same day had difficulty ambulating, immediate swelling, pain, redness and warmth and after unknown latency had cellulitis.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number and expiration date: not provided) in both knees for knee pain.On the same day, patient had immediate swelling and pain the evening of the injection that led to difficulty ambulating.Patient had redness and warmth to the area on the same day.The patient was admitted to the hospital on (b)(6) 2017.The nurse believed the patient was admitted with cellulitis (onset date: 2017, latency: unknown).The patient was discharged from the hospital on (b)(6) 2017.Corrective treatment: not reported for all events.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: hospitalization for all events.Pharmacovigilance comment: sanofi company comment dated 26-dec-2017: this case concerns a female patient who received synvisc one injection and later was hospitalised for cellulitis and difficulty ambulating.Based upon the temporal gap, the causal role of the product cannot be denied with the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.

Event Description

This unsolicited case from united states was received on 19-dec-2017 from nurse.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and on the same day had difficulty ambulating, immediate swelling, pain, redness and warmth and after unknown latency had cellulitis.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number and expiration date: not provided) in both knees for knee pain.On the same day, patient had immediate swelling and pain the evening of the injection that led to difficulty ambulating.Patient had redness and warmth to the area on the same day.The patient was admitted to the hospital on (b)(6) 2017.The nurse believed the patient was admitted with cellulitis (onset date: 2017, latency: unknown).The patient was discharged from the hospital on (b)(6) 2017.Corrective treatment: not reported for all events outcome: unknown for all events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) 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.Sanofi 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.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: hospitalization for all events follow up was received on 11-jan-2018.No new information was received.Additional information was received on 30-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 30-jan-2017: follow up information received does not changes previous case assessment.This case concerns a female patient who received synvisc one injection and later was hospitalised for cellulitis and difficulty ambulating.Based upon the temporal gap, the causal role of the product cannot be denied with the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7189190
• MDR Text Key: 97291280
• Report Number: 2246315-2017-00568
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization