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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Toxicity (2333); Reaction (2414)

Event Type  malfunction  

Event Description

This case is cross referenced with case: (b)(4).(cluster).This unsolicited case from united states was received on 21-dec-2017 from a nurse.This case concerns a patient of unknown demographics who received treatment with synvisc one and later after unknown latency presented to the er (emergency room)/ significant reactions (unevaluable event).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, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021; expiry date: unknown).On an unknown date, after unknown latency the patient had significant reactions and presented to the emergency room (er) (unevaluable event).Action taken: unknown.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 dated 28-dec-2017: this case concerns a patient who experienced significant reactions and went to er after receiving synvisc one injection from the recalled lot.Temporal relationship cannot be established between the event and the suspect product based on the available information.However, as the concerned lot number has been identified to have malfunction by the company.Therefore, the pharmacological plausibility of the events to the product cannot be excluded completely.

• 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: 7178849
• MDR Text Key: 97804882
• Report Number: 2246315-2017-00603
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other