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

Lot Number 6RSL028

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

Patient Problem Anaphylactic Shock (1703)

Event Date 04/12/2017

Event Type  Injury  

Event Description

This unsolicited case from (b)(6) was received on 30- jun-2017 and 3-jul-2017 (processed together on 30-jun- 2017) from the patient (nurse in internal medicine).This case concerns a (b)(6) female patient who received treatment with synvisc injection and after 15 minutes the patient experienced anaphylactic shock.No relevant medical history, past drugs and concomitant medications were reported.Patient had history of unspecified allergy.On an unknown date in (b)(6) 2017, the patient received treatment with intra-articular synvisc injection (dose, frequency, lot number and expiration date: not reported) in both the knees.The same day, 15 minutes after receiving the injection patient developed an anaphylactic shock.Patient received epinephrine injection, cortisone and allergy medicine as corrective treatment.Action taken: unknown.Corrective treatment: epinephrine injection; cortisone.And allergy medicine.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated with (b)(4) and results were pending for the same.Seriousness criterion: required intervention.

Event Description

This unsolicited case from (b)(6) was received on (b)(6) 2017 and (b)(6) 2017 (processed together on (b)(6) 2017) from the patient (nurse in internal medicine).This case concerns a (b)(6) year old female patient who received treatment with synvisc injection and after 15 minutes the patient experienced anaphylactic shock.No relevant medical history, past drugs and concomitant medications were reported.Patient had history of unspecified allergy.On an unknown date in (b)(6) 2017, the patient received treatment with intra-articular synvisc injection (dose, frequency, lot number and expiration date: not reported) in both the knees.The same day, 15 minutes after receiving the injection patient developed an anaphylactic shock.Patient received epinephrine injection, cortisone and allergy medicine as corrective treatment.Action taken: unknown.Corrective treatment: epinephrine injection; cortisone and allergy medicine.Outcome: unknown.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 will continue to monitor adverse events to determine if a capa is required.Seriousness criterion: required intervention.Additional information was received on 06-jul-2017.Ptc results were added.Text was amended accordingly.

Event Description

Based on additional information received on 21-aug- 2017, suspect product was updated from synvisc to synvisc one this unsolicited case from (b)(6) was received on 30- jun-2017 and 3-jul-2017 (processed together on 30-jun-2017) from the patient (nurse in internal medicine).This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after 15 minutes the patient experienced anaphylactic shock.No relevant past drugs and concomitant medications were reported.Patient had history of unspecified allergy.Patient had medical history of pain.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once (lot number: 6rsl028 and expiration date: 30- jun-2019) in both the knees for arthrosis of the knee at the private clinic.The same day, approximately 10 minutes after patient had left the clinic, patient started coughing and after that she experienced feeling of tightness and itching of the throat little by little.The patient took 20 mg of cortisone (nos) orally as well as epinephrine (adrenaline) injection and desloratadine (aerius) just in case and the situation (coughing, feeling of tightness and itching of the throat) alleviated.However, on the next day the patient still felt sticky, hoarse feeling in the throat.It was reported that the patient developed an anaphylactic shock.The patient stated that she received fairly good response synvisc one injection.It was reported that the pain did not disappear completely, but it became much better after synvisc one injections.Corrective treatment: epinephrine (adrenaline) injection; cortisone and desloratadine (aerius).Outcome: unknown.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 will continue to monitor adverse events to determine if a capa is required.Seriousness criterion: required intervention additional information was received on 06-jul-2017.Ptc results were added.Text was amended accordingly.Additional information was received on 21-aug-2017 from nurse.Suspect product was updated from synvisc to synvisc one.Suspect product details updated.Clinical course was updated and text was amended accordingly.

Event Description

Based on additional information received on 21-aug- 2017, suspect product was updated from synvisc to synvisc one.This unsolicited case from (b)(6) was received on 30- jun-2017 and 3-jul-2017 (processed together on 30-jun- 2017) from the patient (nurse in internal medicine).This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after 15 minutes the patient experienced anaphylactic shock.No relevant past drugs and concomitant medications were reported.Patient had history of unspecified allergy.Patient had medical history of pain.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once (lot number: 6rsl028 and expiration date: 30- jun-2019) in both the knees for arthrosis of the knee at the private clinic.The same day, approximately 10 minutes after patient had left the clinic, patient started coughing and after that she experienced feeling of tightness and itching of the throat little by little.The patient took 20 mg of cortisone (nos) orally as well as epinephrine (adrenaline) injection and desloratadine (aerius) just in case and the situation (coughing, feeling of tightness and itching of the throat) alleviated.However, on the next day the patient still felt sticky, hoarse feeling in the throat.It was reported that the patient developed an anaphylactic shock.The patient stated that she received fairly good response synvisc one injection.It was reported that the pain did not disappear completely, but it became much better after synvisc one injections.Corrective treatment: epinephrine (adrenaline) injection; cortisone and desloratadine (aerius).Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).The production and quality control documentation for lot # 6rsl028, with expiration date (06/2019) 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 # 6rsl028, no capa was 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 had not indicated any safety issue.Sanofi would continue to monitor complaints in order to determine if a capa was required.Seriousness criterion: required intervention.Additional information was received on 06-jul-2017.Ptc results were added.Text was amended accordingly.Additional information was received on 21-aug-2017 from nurse.Suspect product was updated from synvisc to synvisc one.Suspect product details updated.Clinical course was updated and text was amended accordingly.Follow up was received on 22-aug-2017.No new information was received.Additional information was received on 29-aug-2017.Investigation summary of synvisc one received and processed.Text was amended accordingly.

• 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: 6740935
• MDR Text Key: 80942757
• Report Number: 2246315-2017-00109
• 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,Followup,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 06/30/2019
• Device Lot Number: 6RSL028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2017
• 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: 57 YR