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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthralgia (2355); No Code Available (3191)
Event Date 11/29/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 11-apr-2018 from a patient. This case concerns a (b)(6) male patient who received treatment with synvisc one injection and experienced could barely walk/almost fell/hard time walking/trouble walking (6 hours), my leg was 2-3 times the size/knee to hip swollen/leg swells up a bit (after 01 days), couldn't put weight on it (few days), stiff (on the same day), hurting a little bit/ knee started hurting (on the same day), broke out in painful puss balls/would pop and hurt/ mostly on my left leg and shoulders and upper chest/ anywhere from knee up through ( after few weeks) and couldn't get comfortable (on the same day). No medical history, past drugs concomitant medications and concurrent conditions were reported. On an unknown date in (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, once (dose, and indication unknown) in left knee. On an unknown date in (b)(6) 2017, 6 hours after receiving the synvisc one injection, patient could barely walk and patient called his doctor and they told him to go home. Patient was at work. Patient was getting in and out of vehicles all day. On the same day, patient noticed that he was stiff and hurting a little bit around 2 pm and his knee started hurting and he couldn't get comfortable. Patient got up to walk and almost fell and couldn't put weight on it. He went home and put ice on it and elevated it. Patient did that all night that wednesday. On an unknown date in (b)(6) 2017, the next morning, patient had pain in walking and realized that my leg was 2-3 times the size. The socks patient was wearing were embedded in my calf. His niece came down. They told him to keep elevated and ice 20 min/hr. On friday, patient slept in recliner to keep leg up. Woke up and could barely walk and not put weight on it. Stumbled around. Had a cane. Friday patient couldn't get going and needed the cane to walk to restroom. Swelling was worse. Patient saw doctor and patient was to hospital to see if i had blood clot. They did an us which was negative. Went home and elevate/ice. On saturday, ankle and bottom part of leg was normal. , swelling gone. On sunday, calf swelling gone down but till hard time walking. On monday: trouble walking and swelling was down. Didn't work. On tuesday, patient's knee to hip swollen but everything below as normal. Patient still had pain walking and went to work. Sunday night, didn't need the cane. Wednesday/thursday of next week, swelling gone. In the next month, patient had a blood test which was negative. On an unknown date, few weeks after the first injection, patient broke out in painful puss balls and they would pop and hurt. They were mostly on my left leg and shoulders and upper chest. Anywhere from knee up through. Patient haven't had them in a few weeks. Resolved. Patient's knee does feel good now that medication was in and working in. Every once in a while his leg swells up a bit. Never got red. Patient don't remember what he did to numb. He may have used spray first time hydrocortisone (cortizone) twice. Corrective treatment: ice, elevation, cane for could barely walk/almost fell/hard time walking/trouble walking; ice, elevation, hydrocortisone (cortizone) for my leg was 2-3 times the size/knee to hip swollen/leg swells up a bit, couldn't put weight on it, stiff, hurting a little bit/ knee started hurting; not reported for rest of the events outcome: recovering/ resolving for couldn't get comfortable, could barely walk/almost fell/hard time walking/trouble walking, my leg was 2-3 times the size/knee to hip swollen/leg swells up a bit, couldn't put weight on it, stiff, hurting a little bit/ knee started hurting; recovered/ resolved for broke out in painful puss balls/would pop and hurt/ mostly on my left leg and shoulders and upper chest/ anywhere from knee up through seriousness criteria: disability for could barely walk/almost fell/hard time walking/trouble walking, required intervention for my leg was 2-3 times the size/knee to hip swollen/leg swells up a bit, couldn't put weight on it, stiff, hurting a little bit/ knee started hurting a product technical complaint (ptc) was initiated and results were pending for the same. Pharmacovigilance comment: sanofi company comment dated 18-apr-2018: based on the available information, pharmacological plausibility can be established between the events and suspect product. However, more information regarding injection techniques, lot number, patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications and other risk factors is required for further case assessment.
 
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Brand NameSYNVISC ONE
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 Key7483666
MDR Text Key107256444
Report Number2246315-2018-00462
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 consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/30/2018
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: 05/03/2018 Patient Sequence Number: 1
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