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

Lot Number 4RSE005D

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

Patient Problems Loss of consciousness (2418); Sweating (2444); No Code Available (3191)

Event Type  Injury  

Event Description

Based on additional information received on 30-jun- 2017, this case previously considered as non-valid became valid and also initially considered as nonserious was upgraded to serious as additional serious events of profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg with the seriousness criteria of required intervention was added.This unsolicited case from (b)(6) was received on 29-jun-2017 from a physician.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and later after unknown latencies experienced profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg.The patient had no previous history of drug allergy or any previous intra-articular infection.No relevant past drug, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra- articular synvisc one injection, once (dose: not provided; batch/lot and expiration date: 4rse005d, aug- 2017) for early degeneration knee.On an unspecified date, after unknown latency, the patient experienced profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg.Reportedly, the patient was treated with iv fluids, hydrocortisone; dexamethasone (decadron) and atropine sulfate (atropine).Corrective treatment: iv fluids, hydrocortisone dexamethasone (decadron) and atropine sulfate (atropine) for all the events.Outcome: recovered/ resolved.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: required intervention for all the events.Additional information was received on 30-jun-2017 from the physician.Patient's gender, weight, age and medical history were added.This case previously considered as non-valid became valid and also initially considered as non-serious was upgraded to serious as additional serious events of profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg with the seriousness criteria of required intervention was added.The batch/lot and expiration date: 4rse005d, aug-2017 and indication of the suspect were added.Additional events of profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg with details was added.Pharmacovigilance comment: sanofi company comment dated 5-jul-2017: this case concerns a patient who received treatment with synvisc one and later experienced excess sweating, decreased consciousness, pulse and blood pressure along with tongue discoloration.Although temporal relationship cannot be established, the causal role of suspect product cannot be completely denied in occurrence of the events.However due to lack of information regarding medical history, concurrent conditions, concomitant medications, lab data and past drugs complete medical assessment of the case is difficult.

Event Description

Based on additional information received on 30-jun- 2017, this case previously considered as non-valid became valid and also initially considered as nonserious was upgraded to serious as additional serious events of profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg with the seriousness criteria of required intervention was added.This unsolicited case from (b)(6) was received on 29- jun-2017 from a physician.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and later after unknown latencies experienced profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg the patient had no previous history of drug allergy or any previous intra-articular infection.No relevant past drug, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra- articular synvisc one injection, once (dose: not provided; batch/lot and expiration date: 4rse005d, aug- 2017) for early degeneration knee.On an unspecified date, after unknown latency, the patient experienced profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg.Reportedly, the patient was treated with iv fluids, hydrocortisone; dexamethasone (decadron) and atropine sulfate (atropine) corrective treatment: iv fluids, hydrocortisone dexamethasone (decadron) and atropine sulfate (atropine) for all the events.Outcome: recovered/ resolved.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).The production and quality control documentation for lot # 4rse005d expiration date (08/2017) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot frequency analysis for lot 4rse005d no capa was required.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.As of 04-aug-17, there was only 1 complaint on file for 4rse005d: 1 adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.Seriousness criteria: required intervention for all the events additional information was received on 30-jun-2017 from the physician.Patient's gender, weight, age and medical history were added.This case previously considered as non-valid became valid and also initially considered as non-serious was upgraded to serious as additional serious events of profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg with the seriousness criteria of required intervention was added.The batch/lot and expiration date: 4rse005d, aug-2017 and indication of the suspect were added.Additional events of profuse sweating, decreased consciousness, tongue white and pale, decreased pulse and blood pressure 90/40 mm hg with details was added.Additional information was received on 09-aug-2017.Global ptc number and results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 9-aug-2017: the follow up information received did not change the previous case assessment.This case concerns a patient who received treatment with synvisc one and later experienced excess sweating, decreased consciousness, pulse and blood pressure along with tongue discoloration.Although temporal relationship cannot be established, the causal role of suspect product cannot be completely denied in occurrence of the events.However due to lack of information regarding medical history, concurrent conditions, concomitant medications, lab data and past drugs complete medical assessment of the case is difficult.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 6724204
• MDR Text Key: 80407570
• Report Number: 2246315-2017-00110
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

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 Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Lot Number: 4RSE005D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 85