• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problem Inflammation (1932)
Event Date 10/01/2017
Event Type  malfunction  
Event Description
Based on additional information received on 30-mar- 2018, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as required intervention and previously reported nonserious event of pseudoseptic reaction was considered serious with seriousness criteria as required intervention. This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on 28-dec-2017 from physician. This case concerns a female patient who received treatment with synvisc one and later after unknown latency had pseudoseptic reaction and fluid was aspirated from both knees. Also device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection once (dose and indication: unknown) on both knees (batch/lot number: 7rsl021; expiration date: 30-sep-2020). On an unknown date in (b)(6) 2017, after unknown latency, patient had pseudoseptic reaction. On an unknown date in (b)(6) 2017, after unknown latency the patient's fluid was aspirated from both knees. It was reported that the physician injected cortisone to both knees. On (b)(6) 2017, the patient returned with both knees "blown up". The patient returned 2 weeks later on (b)(6) 2017 and was still inflamed and "angry". Physician drew fluid from the knee and sent it for "routine analysis" but nothing grew out. The last contact with this patient was on (b)(6) 2017, when patient stated that patient was "better" but still having pain. On an unknown date, the events resolved with no additional swelling. Corrective treatment: not reported for fluid was aspirated from both knees and device malfunction; cortisone. For pseudoseptic reaction. Outcome: recovered for all the events. Seriousness criteria: required intervention for device malfunction and pseudoseptic reaction. A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4). An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events was under investigation. Once this investigation would be completed, corrective and preventive actions would be implemented. Additional information was received on 27-feb-2018. Global ptc number and ptc results added. Text was amended accordingly. Additional information was received on 30-mar-2018 from the physician. This case initially considered nonserious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as required intervention and previously reported non-serious event of pseudoseptic reaction was considered serious with seriousness criteria as required intervention. Also the additional event of fluid was aspirated from both knees was added with details. The suspect product batch/lot number and expiry date was added. Clinical course updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 30-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pseudoseptic reaction including swelling, pain, inflammation of knees and fluid was aspirated from both knees. A temporal relationship can be established with the product administration. In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7431554
MDR Text Key106024535
Report Number2246315-2018-00447
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
Remedial Action Recall
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2018
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: 04/14/2018 Patient Sequence Number: 1
-
-