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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Chills (2191); Joint Swelling (2356)
Event Type  Injury  
Event Description
Based on additional information received on 30-jan- 2018, this case initially considered as non-serious was upgraded to serious as the seriousness criterion of hospitalization was added to events of nausea, leg couldn't move, could hardly walk, felt cold, chills/had shivers, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee this case was cross reference with (b)(4) (duplicate). This unsolicited case from (b)(6) was received on 16- jan-2018 from a physician. This case concerns a female patient (age not provided) who received treatment with synvisc injection and after unknown latency had nausea, her knee got more swollen/ it took another 2-3 weeks before the swelling in my knee disappeared, leg couldn't move, could hardly walk, felt cold, had shivers, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee, painful over the day and had chills/had shivers no medical history and concomitant medication was provided. Patient received 2-3 times per year and had good effect with them, but it was not infectious. Patient had a lot of other allergies. On an unknown date in (b)(6) 2017, patient initiated treatment with intra- articular synvisc injection (dose, frequency, batch/lot number and expiration date: not provided) for osteoarthritis. During last set of injections in (b)(6) 2017, there were no issues for needles 1 and 2 of synvisc. However, after third and last needle on (b)(6) 2017, there was a strong reaction on right knee. About 10 hours after the injection, patient leg could not move and could hardly walk and felt cold, had shivers and was nauseas. By 10 pm patient was in emergency at the (b)(6) hospital. They extracted lots of fluid from my knee, which was negative for infection. On the same day, patient was hospitalized after a synvisc injection in right knee which resulted in aspiration of over 30 cc of fluid. This reaction was a great surprise. Synvisc had been patient viscosupplement of choice since it performed far better than several other brands patient had tried in the past. Patient sports medicine doctor requested an allergy test before any further injections are made. On an unknown date, latency unknown, patient had chills and nausea. Patient's knee got progressively more swollen and painful over the day. It took another 2-3 weeks before the swelling in my knee disappeared (onset date: unknown; latency unknown) corrective treatment: fluid aspirated 30 cc for had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee; not reported for rest events outcome: not recovered for nausea, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee; recovered for painful over the day; unknown for rest events a pharmaceutical technical complaint was initiated with results pending for the same. Seriousness criterion: hospitalization for nausea, leg couldn't move, could hardly walk, felt cold, chills/had shivers, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee additional information was received on 30-jan-2018 from patient. This case initially considered as non-serious was upgraded to serious as the seriousness criterion of was added to events of nausea, leg couldn't move, could hardly walk, felt cold, chills/had shivers, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee. Verbatim was updated for the event of knee got progressively more swollen to her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared; chills to chills/had shivers. Event of leg couldn't move, could hardly walk, felt cold, strong reaction on right knee were added along with its details. Product start date updated. Clinical course updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 30-jan-2018. This case concerns a patient who received synvisc injection and later experienced difficulty moving, difficulty walking, feeling cold, shivering and nausea. Based upon the information available, the causal role of the product cannot be denied for the occurrence of events. However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection. Further information regarding patient's current clinical presentation, medical history, concomitant and past medications and other risk factors precludes the complete medical case assessment.
 
Event Description
Based on additional information received on 30-jan- 2018, this case initially considered as non-serious was upgraded to serious as the seriousness criterion of hospitalization was added to events of nausea, leg couldn't move, could hardly walk, felt cold, chills/had shivers, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee this case was cross reference with case id (b)(4) (duplicate) this unsolicited case from canada was received on 16- jan-2018 from a physician. This case concerns a female patient (age not provided) who received treatment with synvisc injection and after unknown latency had nausea, her knee got more swollen/ it took another 2-3 weeks before the swelling in my knee disappeared, leg couldn't move, could hardly walk, felt cold, had shivers, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee, painful over the day and had chills/had shivers no medical history and concomitant medication was provided. Patient received 2-3 times per year and had good effect with them, but it was not infectious. Patient had a lot of other allergies. On an unknown date in (b)(6) 2017, patient initiated treatment with intra- articular synvisc injection (dose, frequency, batch/lot number and expiration date: not provided) for osteoarthritis. During last set of injections in jun-2017, there were no issues for needles 1 & 2 of synvisc. However, after third and last needle on (b)(6) 2017, there was a strong reaction on right knee. About 10 hours after the injection, patient leg could not move and could hardly walk and felt cold, had shivers and was nauseas. By 10 pm patient was in emergency at the civic hospital. They extracted lots of fluid from my knee, which was negative for infection. On the same day, patient was hospitalized after a synvisc injection in right knee which resulted in aspiration of over 30cc of fluid. This reaction was a great surprise. Synvisc had been patient viscosupplement of choice since it performed far better than several other brands patient had tried in the past. Patient sports medicine doctor requested an allergy test before any further injections are made. On an unknown date, latency unknown, patient had chills and nausea. Patient's knee got progressively more swollen and painful over the day. It took another 2-3 weeks before the swelling in my knee disappeared (onset date: unknown; latency unknown) corrective treatment: fluid aspirated 30cc for had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee; not reported for rest events outcome: not recovered for nausea, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee; recovered for painful over the day; unknown for rest events a pharmaceutical technical complaint was initiated with gptc 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 would continue to monitor adverse events to determine if a capa was required. Seriousness criterion: hospitalization for nausea, leg couldn't move, could hardly walk, felt cold, chills/had shivers, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee additional information was received on 30-jan-2018 from patient. This case initially considered as non-serious was upgraded to serious as the seriousness criterion of was added to events of nausea, leg couldn't move, could hardly walk, felt cold, chills/had shivers, her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared, had aspiration/aspiration of over 30 cc of fluid/ extracted lots of fluid from my knee, strong reaction on right knee. Verbatim was updated for the event of knee got progressively more swollen to her knee got more swollen/it took another 2-3 weeks before the swelling in my knee disappeared; chills to chills/had shivers. Event of leg couldn't move, could hardly walk, felt cold, strong reaction on right knee were added along with its details. Product start date updated. Clinical course updated. Text was amended accordingly. Additional information was received on 27-feb-2018 from patient. Global ptc number and ptc results were added. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 27-feb-2018. This case concerns a patient who received synvisc injection and later experienced difficulty moving, difficulty walking, feeling cold, shivering and nausea. Based upon the information available, the causal role of the product cannot be denied for the occurrence of events. However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection. Further information regarding patient's current clinical presentation, medical history, concomitant and past medications and other risk factors precludes the complete medical case assessment.
 
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Brand NameSYNVISC (SYNVISC)
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7272495
MDR Text Key100121401
Report Number2246315-2018-00275
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,foreign,health profe
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/27/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 02/15/2018 Patient Sequence Number: 1
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