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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2018 from other non-health care professional (patient care giver) this case concerns a (b)(6) year old male patient who received treatment with synvisc one.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication was provided.Patient had pain and used a cane.On an unknown date in (b)(6) 2017 (2 months ago), the patient initiated treatment with intra-articular synvisc one injection once (batch/lot number: 7rsl021; frequency, indication and expiry date: unknown).It was reported that patient had no new problems since then.Patient was still in pain but that he had before the injection too.Patient used a cane once in a while but that he was using before too.Patient might have gotten some blood work done after the injection but it was normal.Care giver said she did not think patient has had other products like this before nor did he have a pacemaker or device.Corrective treatment: not reported.Outcome: unknown.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 for (b)(6) 2018: this case concerns a male patient who received synvisc one injection from the recalled lot.Later the concerned lot number was identified to be malfunctioned by the company.However, there is no adverse event reported by the consumer hence this single case report does not alter the benefit/risk profile of the product.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-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 Key: 7269203
• MDR Text Key: 100282585
• Report Number: 2246315-2018-00268
• Device Sequence Number: 0
• Product Code: MOZ
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR