• 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 Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Swelling (2091)
Event Date 01/01/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 21-mar-2018 from a non-healthcare professional. This case involves a patient of unknown demographics who received treatment with synvisc one and later after few hours had severe pain, swelling and stiffness. Also device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. On an unknown date in 2017, the initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (indication: unknown) into the left knee (batch/lot number: 7rsl021 and expiry date: unknown). Within 24 hours, the patient had severe pain, swelling, stiffness. The product was not compounded not over the counter. Corrective treatment: not reported for all the events. Outcome: unknown for all the events. 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. Seriousness criteria: important medical event for device malfunction. Pharmacovigilance comment: sanofi company comment dated 30-mar-2018. This case concerns a patient who presented left knee pain, swelling and stiffness after receiving treatment with synvisc one injection from recall lot. Temporal relationship can be established between the events and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company. Therefore, pharmacological plausibility 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 Key7402040
MDR Text Key105261016
Report Number2246315-2018-00438
Device Sequence Number0
Product Code MOZ
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2018 Patient Sequence Number: 1
-
-