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

Lot Number UNKNOWN

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

Patient Problems Dyspnea (1816); Headache (1880); Unspecified Infection (1930)

Event Date 07/22/2016

Event Type  Injury  

Event Description

This unsolicited case from united states was received on (b)(6) 2016 from a patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc and 1 day later experienced dizziness, vomiting, headache, after 21 days was sick, few weeks after was nauseous, cold chills, sweats, respiratory difficulty, legs swelled arm swelled, urinary tract infection, uti that travelled upto her kidneys, septic, after few days had flu and after few weeks her memory has vanished.The patient's medical history, past drugs, concurrent condition and concomitant medications were not reported.On (b)(6) 2016, the patient initiated treatment with intra-articular synvisc injection at a dose of 2 ml, (batch/lot number and expiration date: not reported) in the right knee for meniscus tear right knee.On (b)(6) 2016, after 1 day of initiating treatment with synvisc experienced dizziness, headache, and vomiting.It was reported that the doctor did not tell the patient anything about the injections or gave her any paperwork before her injection.The patient was only told that the injection was going to lubricate her knee.On (b)(6) 2016 (2 weeks later), the patient received second injection of synvisc.On (b)(6) 2016, 21 days of initiating treatment with synvisc, the patient was sick that she could not stand it.On (b)(6) 2016, the patient could not get out of bed.On (b)(6) 2016, the patient had to crawl to her car and drive to emergency room.It was reported that the patient had to put the car in part because she lost her vision, she was so dizzy.The patient was transferred from emergency room and admitted to another hospital where she stayed for three and a half days.On an unknown date in (b)(6) 2016, few weeks after initiating treatment with synvisc, the patient ended up with severe headache, nauseousness, cold chills, and sweats.Also, the patient had respiratory difficulty, her legs swelled and arm swelled.The patient was diagnosed with urinary tract infection that travelled up to her kidneys.The patient could correlate that with synvsic injections she received because no one around her was sick.Further reported, the patient became septic and her memory had vanished.The patient was told by doctors that she could have died if she did not come into the hospital.The patient also experienced flu and it lasted for a couple of days.Also, the patient was told that e-coli were found developing in her urine sample.The patient did not realize all of these symptoms could be related to synvisc.Action taken: unknown.Corrective treatment: not reported for all events.Outcome: unknown for all the events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: hospitalization for dizziness, headache, sick, nauseous, cold chills, sweats, respiratory difficulty, legs swelled arm swelled, urinary tract infection, uti that travelled upto her kidneys, septic, pharmacovigilance comment: sanofi company comment dated (b)(6) 2016: this case is regarding a patient who starting receiving therapy with synvisc and was hospitalized due to dizziness, malaise, severe headaches, nausea, chills, hyperhidrosis, dyspnea, difficulty breathing, and urinary tract infection that travelled to kidney and became septic.Based upon the positive temporal relationship the causal role of product cannot be denied from the occurrence of the events.However, since there is no information provided regarding patient's medical history and concurrent conditions a comprehensive case assessment is difficult.Furthermore, information regarding the technique of injection and the conditions under which the synvisc was administered is required to make complete assessment.

Event Description

This unsolicited case from united states was received on (b)(6) 2016 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc and 1 day later experienced dizziness, vomiting, headache, after 21 days was sick, few weeks after was nauseous, cold chills, sweats, respiratory difficulty, legs swelled arm swelled, urinary tract infection, uti that travelled upto her kidneys, septic, after few days had flu and after few weeks her memory has vanished.The patient's medical history, past drugs, concurrent condition and concomitant medications were not reported.On (b)(6) 2016, the patient initiated treatment with intra-articular synvisc injection at a dose of 2 ml, (batch/lot number and expiration date: not reported) in the right knee for meniscus tear right knee.On (b)(6) 2016, after 1 day of initiating treatment with synvisc experienced dizziness, headache, and vomiting.It was reported that the doctor did not tell the patient anything about the injections or gave her any paperwork before her injection.The patient was only told that the injection was going to lubricate her knee.On (b)(6) 2016 (2 weeks later), the patient received second injection of synvisc.On (b)(6) 2016, 21 days of initiating treatment with synvisc, the patient was sick that she could not stand it.On (b)(6) 2016, the patient could not get out of bed.On (b)(6) 2016, the patient had to crawl to her car and drive to emergency room.It was reported that the patient had to put the car in part because she lost her vision, she was so dizzy.The patient was transferred from emergency room and admitted to another hospital where she stayed for three and a half days.On an unknown date in (b)(6) 2016, few weeks after initiating treatment with synvisc, the patient ended up with severe headache, nauseousness, cold chills, and sweats.Also, the patient had respiratory difficulty, her legs swelled and arm swelled.The patient was diagnosed with urinary tract infection that travelled up to her kidneys.The patient could correlate that with synvsic injections she received because no one around her was sick.Further reported, the patient became septic and her memory had vanished.The patient was told by doctors that she could have died if she did not come into the hospital.The patient also experienced flu and it lasted for a couple of days.Also, the patient was told that e-coli were found developing in her urine sample.The patient did not realize all of these symptoms could be related to synvisc.Action taken: unknown.Corrective treatment: not reported for all events.Outcome: unknown for all the 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 genzyme 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 genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: hospitalization for dizziness, headache, sick, nauseous, cold chills, sweats, respiratory difficulty, legs swelled arm swelled, urinary tract infection, uti that travelled upto her kidneys, septic additional information was received on (b)(6) 2016: global ptc number and ptc results were added.Pharmacovigilance comment: sanofi company comment dated 24-aug-2016: the follow up information received does not change previous case assessment.Sanofi company comment dated 23-aug-2016: this case is regarding a patient who starting receiving therapy with synvisc and was hospitalized due to dizziness, malaise, severe headaches, nausea, chills, hyperhidrosis, dyspnea, difficulty breathing, and urinary tract infection that travelled to kidney and became septic.Based upon the positive temporal relationship the causal role of product cannot be denied from the occurrence of the events.However, since there is no information provided regarding patient's medical history and concurrent conditions a comprehensive case assessment is difficult.Furthermore, information regarding the technique of injection and the conditions under which the synvisc was administered is required to make complete assessment.

• Brand Name: SYNVISC
• 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: 5904182
• MDR Text Key: 53037184
• Report Number: 2246315-2016-00126
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2016
• 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): Hospitalization