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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ
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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ Back to Search Results
Device Problem Device Contamination With Biological Material (2908)
Patient Problem Arthralgia (2355)
Event Type  Injury  
Event Description
Based on additional information received on 28-mar- 2018, this case initially considered non-serious was upgraded to serious as the serious event of knee pain is not any better after shots with seriousness criteria as required intervention was added.This unsolicited case from united states was received on (b)(4) 2018 from patient.This case involves a (b)(6) year old female patient who received treatment with synvisc one and was upset because she thought it was going to work and it hasn't yet (latency: 0 day) and after unknown latency knee pain was not any better after shots.Relevant past drugs were not reported.Patient received cortisone injections for sometime prior to synvisc-one treatment and receive a "booster shot" of cortisone at the time of synvisc-one injection.The medical history included gallbladder removal, drug allergy (penicillin and sulphur; hives and swelling).The concomitant medications included atorvastatin for cholesterol, metoprolol tartrate (metoprolol) and amlodipine besilate for blood pressure and cranberry extract for urinary.On (b)(6) 2018, patient received bilateral intra-articular synvisc-one injection, once at dose of 48 mg for osteoarthritis.It was reported that patient was very upset because patient thought it was going to work and it hasn't yet.Since an unknown date, after unknown latency the patient's knee pain was not any better after shots.Corrective treatment: steroid injection for knee pain is not any better after shots outcome: not recovered for knee pain is not any better after shots a pharmaceutical technical complaint was initiated with global ptc number: 52962 the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.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.Sanofi will continue to monitor adverse events to determine if a capa is required.Seriousness criteria: required intervention for knee pain is not any better after shots additional information was received on 09-mar-2018.The global ptc number and the results were added.Text amended accordingly.Additional information was received on 28-mar-2018 from the patient.This case initially considered non-serious was upgraded to serious as the serious event of knee pain is not any better after shots with seriousness criteria as required intervention was added with details.The patient's medical history and concomitant medications were added.Clinical course updated.Text was amended accordingly.
 
Event Description
Knee pain is not any better after shots/ hurting so bad [knee pain] ([device ineffective]).Case narrative: based on additional information received on 28-mar-2018, this case initially considered non-serious was upgraded to serious as the serious event of knee pain is not any better after shots with seriousness criteria as required intervention was added.This unsolicited case from united states was received on 05-mar-2018 from patient.This case involves a (b)(6) female patient who received treatment with synvisc one and was upset because she thought it was going to work and it hasn't yet/shot didn't work/didn't do anything (latency: 0 day) and after unknown latency knee pain was not any better after shots.Relevant past drugs were not reported.Patient received cortisone injections for sometime prior to synvisc-one treatment and receive a "booster shot" of cortisone at the time of synvisc-one injection.The medical history included gallbladder removal, drug allergy (penicillin and sulphur; hives and swelling).The concomitant medications included atorvastatin for cholesterol, metoprolol tartrate (metoprolol) and amlodipine besilate for blood pressure and cranberry extract for urinary.On (b)(6) 2018, patient received bilateral intra-articular synvisc-one injection, once at dose of 48 mg for osteoarthritis.It was reported that patient was very upset because she thought it was going to work and it hasn't yet/shot didn't work/didn't do anything.Since an unknown date, after unknown latency the patient's knee pain was not any better after shots.On (b)(6) 2018, the patient reported that she took steroid shots again because she was hurting so bad.Corrective treatment: steroid injection for knee pain is not any better after shots.Outcome: not recovered for knee pain is not any better after shots.A pharmaceutical technical complaint was initiated with global ptc number: (b)(4).A product technical complaint was initiated on 09-mar-2018 for synvisc one, batch number: unknown, 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 is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.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 will continue to monitor adverse events to determine if a capa is still required.Seriousness criteria: required intervention for knee pain is not any better after shots.Additional information was received on 09-mar-2018.The global ptc number and the results were added.Text amended accordingly.Additional information was received on 28-mar-2018 from the patient.This case initially considered non-serious was upgraded to serious as the serious event of knee pain is not any better after shots with seriousness criteria as required intervention was added with details.The patient's medical history and concomitant medications were added.Clinical course updated.Text was amended accordingly.Additional information was received on 06-apr-2018.Global ptc results were added.Text amended accordingly.Follow-up was received on 23-may-2018.Event verbatim of very upset because she thought it was going to work and it hasn't yet was updated to very upset because she thought it was going to work and it hasn't yet/shot didn't work/didn't do anything.Outcome of arthralgia was still not recovered.Text was amended accordingly.
 
Event Description
Based on additional information received on 28-mar- 2018, this case initially considered non-serious was upgraded to serious as the serious event of knee pain is not any better after shots with seriousness criteria as required intervention was added.This unsolicited case from united states was received on 05-mar-2018 from patient.This case involves a 64 year old female patient who received treatment with synvisc one and was upset because she thought it was going to work and it hasn't yet (latency: 0 day) and after unknown latency knee pain was not any better after shots.Relevant past drugs were not reported.Patient received cortisone injections for sometime prior to synvisc-one treatment and receive a "booster shot" of cortisone at the time of synvisc-one injection.The medical history included gallbladder removal, drug allergy (penicillin and sulphur; hives and swelling).The concomitant medications included atorvastatin for cholesterol, metoprolol tartrate (metoprolol) and amlodipine besilate for blood pressure and cranberry extract for urinary.On (b)(6) 2018, patient received bilateral intra- articular synvisc-one injection, once at dose of 48 mg for osteoarthritis.It was reported that patient was very upset because patient thought it was going to work and it hasn't yet.Since an unknown date, after unknown latency the patient's knee pain was not any better after shots.Corrective treatment: steroid injection for knee pain is not any better after shots outcome: not recovered for knee pain is not any better after shots a pharmaceutical technical complaint was initiated with global ptc number: (b)(4) the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.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.Sanofi will continue to monitor adverse events to determine if a capa is required.Seriousness criteria: required intervention for knee pain is not any better after shots additional information was received on 09-mar-2018.The global ptc number and the results were added.Text amended accordingly.Additional information was received on 28-mar-2018 from the patient.This case initially considered non-serious was upgraded to serious as the serious event of knee pain is not any better after shots with seriousness criteria as required intervention was added with details.The patient's medical history and concomitant medications were added.Clinical course updated.Text was amended accordingly.Additional information was received on 06-apr-2018.Global ptc results were added.Text amended accordingly.
 
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Brand Name
SYNVISC ONE
Type of Device
MOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7440061
MDR Text Key105800782
Report Number2246315-2018-00446
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Was the Report Sent to FDA? No
Date Manufacturer Received04/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMLODIPINE BESILATE (AMLODIPINE BESILATE),UNKNOWN; AMLODIPINE BESILATE(CON.) ONGOING; AMLODIPINE BESILATE(CON.) ONGOING; ATORVASTATIN (ATORVASTATIN),UNKNOWN; ATORVASTATIN(CON.) ONGOING; ATORVASTATIN(CON.) ONGOING; CORTISONE (CORTISONE),UNKNOWN; CORTISONE(CON.); CORTISONE(CON.); METOPROLOL (METOPROLOL),TABLET; METOPROLOL(CON.) ONGOING; METOPROLOL(CON.) ONGOING; AMLODIPINE BESILATE(CON.) ONGOING; ATORVASTATIN(CON.) ONGOING; CORTISONE(CON.); METOPROLOL(CON.) ONGOING
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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