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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Synovitis (2094); Chills (2191); Arthralgia (2355); No Code Available (3191)
Event Date 12/01/2017
Event Type  Injury  
Event Description
Based on additional information received on 19-jan- 2018, this case initially considered non-serious was upgraded to serious as the serious events of inflammation was added with seriousness criteria as required intervention. This unsolicited case from united states was received on 20-dec-2017 from patient. This case concerns a 56 years old female patient who received treatment with synvisc one injection and on the same day had inflammation, difficulty walking/ virtually any activity and nausea, after unknown latency had an allergic reaction/very quick adverse reaction that required subsequent immediate medical attention that affected her new job. No concomitant medication and concurrent condition was provided. Patient had received synvisc one before 1. 5 years ago, and did not have any side effects. The injection helped the osteoarthritis in (her) right knee. The patient had drug allergy to cillins, myacins and cyclines (rash). On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection; recalled lot at a dose of 1 df once (batch/lot number and expiration date: not provided) in right knee for osteoarthritis. This was the second synvisc one injection. The same day, the patient had inflammation, pain and stiffness in right knee, resulted in swelling to over 2x the size. Also the patient had nausea and difficulty walking or virtual any activity on the same day. The patient was given steroid shot for inflammation. The patient had 2nd orthopaedic opinion and got knee aspiration of 60 cc fluid. On an unknown date, after unknown latency, patient had experienced an allergic reaction, very quick adverse reaction that required subsequent immediate medical attention that affected her new job. On an unknown date, the patient recovered from nausea, inflammation, difficulty walking/virtually any activity. Corrective treatment: steroid shot for inflammation; not reported for other events outcome: unknown for an allergic reaction/very quick adverse reaction that required subsequent immediate medical attention that affected her new job. Recovered for rest of the events. Seriousness criteria: required intervention for inflammation a pharmaceutical technical complaint (ptc) was initiated with gptc number: 51507 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. Additional information was received on 19-jan-2018 from the patient. This case initially considered non-serious was upgraded to serious as the serious events of inflammation, was added with seriousness criteria as required intervention. Also event of nausea was added. The symptoms of inflammation: pain in right knee, stiffness in right knee, swelling to over 2x the size and knee aspirating at 60 cc were added. The suspect product start date, dose, frequency and additional indication of arthritis was added. The information regarding patient's drug allergy was added. Clinical course updated. Text was amended accordingly. Additional information was received on 14-mar-2018. The gptc number with ptc results were added. Text was amended accordingly.
 
Event Description
Based on additional information received on 19-jan- 2018, this case initially considered non-serious was upgraded to serious as the serious events of inflammation was added with seriousness criteria as required intervention. This unsolicited case from united states was received on 20-dec-2017 from patient. This case concerns a (b)(6) female patient who received treatment with synvisc one injection and on the same day had inflammation, difficulty walking/ virtually any activity and nausea, after unknown latency had an allergic reaction/very quick adverse reaction that required subsequent immediate medical attention that affected her new job. No concomitant medication and concurrent condition was provided. Patient had received synvisc one before 1. 5 years ago, and did not have any side effects. The injection helped the osteoarthritis in (her) right knee. The patient had drug allergy to cillins, myacins and cyclines (rash). On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection; recalled lot at a dose of 1 df once (batch/lot number and expiration date: not provided) in right knee for osteoarthritis. This was the second synvisc one injection. The same day, the patient had inflammation, pain and stiffness in right knee, resulted in swelling to over 2x the size. Also the patient had nausea and difficulty walking or virtual any activity on the same day. The patient was given steroid shot for inflammation. The patient had 2nd orthopaedic opinion and got knee aspiration of 60 cc fluid. On an unknown date, after unknown latency, patient had experienced an allergic reaction, very quick adverse reaction that required subsequent immediate medical attention that affected her new job. On an unknown date, the patient recovered from nausea, inflammation, difficulty walking/virtually any activity. Corrective treatment: steroid shot for inflammation; not reported for other events outcome: unknown for an allergic reaction/very quick adverse reaction that required subsequent immediate medical attention that affected her new job. Recovered for rest of the events. Seriousness criteria: required intervention for inflammation a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Additional information was received on 19-jan-2018 from the patient. This case initially considered non-serious was upgraded to serious as the serious events of inflammation, was added with seriousness criteria as required intervention. Also event of nausea was added. The symptoms of inflammation: pain in right knee, stiffness in right knee, swelling to over 2x the size and knee aspirating at 60 cc were added. The suspect product start date, dose, frequency and additional indication of arthritis was added. The information regarding patient's drug allergy was added. Clinical course updated. Text was amended accordingly.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7240604
MDR Text Key296140837
Report Number2246315-2018-00204
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/05/2018 Patient Sequence Number: 1
Treatment
PREMARIN (ESTROGENS CONJUGATED),TABLET
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