• 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 Problems Swelling (2091); Toxicity (2333); Reaction (2414)
Event Type  malfunction  
Event Description
Based on the information received on 30-mar-2018 the case was upgraded to serious as an important medical event of device malfunction was added. 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 (b)(6) female patient who received treatment with synvisc one and later after unknown latency right knee had some mild swelling but the left was very swollen, aspirate and bad pseudoseptic reaction. A device malfunction was noted 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 at a dose of 6 ml once (indication: unknown) bilaterally (left knee only received affected lot) (lot number: 7rsl021; expiry date: 30-sep-2020). On an unknown date in 2017, after unknown latency, the patient's right knee had some mild swelling but the left was very swollen. It was reported that the aspirate also did not grow out. On an unknown date in 2017, after unknown latency, the patient had bad pseudoseptic reaction. As of (b)(6) 2017, the patient was doing good. Corrective treatment: not reported for all the events outcome: unknown for device malfunction; recovering for other events a pharmaceutical technical complaint (ptc) was initiated with (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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: important medical event for device malfunction additional information was received on 14-mar-2018. Ptc results and global ptc number were added. Text was amended accordingly. Additional information was received on 30-mar-2018. Event of device malfunction was added. Lot number was added. Clinical course was updated and text amended accordingly.
 
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 Key7403475
MDR Text Key105252368
Report Number2246315-2018-00444
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 Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 04/06/2018 Patient Sequence Number: 1
-
-