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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 5R5A021
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 11/01/2016
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 14-nov-2016 from the physician. This case involves (b)(6) male patient wit who started treatment with synvisc and 1 day after starting treatment experienced deep vein thrombosis. No medical history, concomitant medication, past drugs or concurrent condition was reported. On an unknown date in (b)(6) 2016 (last week), the patient initiated treatment with first intra-articular synvisc injection of the series, with batch/ lot number: 5r5a021 and expiration date: 2018 (indication and frequency: not reported). The patient called the office the next day reporting soreness and pain in the leg. It was reported that the patient came in to see another health care professional (hcp) in the practice and reported swelling in his foot and ankle. Further reported, the patient was sent to the emergency department immediately for possible deep vein thrombosis (dvt). It was reported that the patient had not had a synvisc injection prior to this; it was his first injection ever. Action taken: unknown. Corrective treatment: not reported. Outcome: unknown. A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criteria: important medical event. Pharmacovigilance comment: sanofi company comment dated 18-nov-2016: this case concerns a male patient who received treatment with synvisc and was later suspected to have experienced deep vein thrombosis with underlying symptoms of ankle and foot swelling with leg pain. On the basis of positive temporal relationship the causal role of suspect cannot be excluded in occurrence of the events. However, lack of detailed information about medical history, concurrent conditions and concomitant medication precludes a comprehensive assessment in this case.
 
Event Description
This unsolicited case from united states was received on 14-nov-2016 from the physician. This case involves (b)(6) male patient wit who started treatment with synvisc and 1 day after starting treatment experienced deep vein thrombosis. No medical history, concomitant medication, past drugs or concurrent condition was reported. On an unknown date in (b)(6) 2016 (last week), the patient initiated treatment with first intra-articular synvisc injection of the series, with batch/ lot number: 5r5a021 and expiration date: aug-2018 (indication and frequency: not reported). The patient called the office the next day reporting soreness and pain in the leg. It was reported that the patient came in to see another health care professional (hcp) in the practice and reported swelling in his foot and ankle. Further reported, the patient was sent to the emergency department immediately for possible deep vein thrombosis (dvt). It was reported that the patient had not had a synvisc injection prior to this; it was his first injection ever. Corrective treatment: not reported. A pharmaceutical technical complaint (ptc) was initiated with (b)(4). The production and quality control documentation for lot # 5r5a021 expiration date (08/2018) 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 # 5r5a021 no capa was required. Sanofi genzyme 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. There were 7 complaints for lot #5rsa021: (2) barrel breakages, (1) barrel breakage/loose finger flange, (1) tip breakage and (3) adverse event reports. Sanofi genzyme would continue to monitor complaints as stated in product complaint handling to determine if a capa was required. Seriousness criteria: important medical event additional information was received on 01-dec-2016. The expiration date of the suspect was updated as aug-2018. Global ptc number with results was added and the text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 01-dec-2016: the additional information does not alter the previous case assessment. Sanofi company comment dated 18-nov-2016: this case concerns a male patient who received treatment with synvisc and was later suspected to have experienced deep vein thrombosis with underlying symptoms of ankle and foot swelling with leg pain. On the basis of positive temporal relationship the causal role of suspect cannot be excluded in occurrence of the events. However, lack of detailed information about medical history, concurrent conditions and concomitant medication precludes a comprehensive assessment in this case.
 
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Brand NameSYNVISC
Type of DeviceINTRA-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 Key6126732
MDR Text Key60850613
Report Number2246315-2016-00174
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date08/01/2018
Device Lot Number5R5A021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/24/2016 Patient Sequence Number: 1
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