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 Bacterial Infection (1735); Sepsis (2067); Toxicity (2333)

Event Type  malfunction  

Event Description

Based on the information received on 08-dec-2017, the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction. This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on 08-dec-2017 from a non-healthcare professional. This case concerns a patient of unknown age and gender who received treatment with synvisc one and later after unknown latency patient had pseudosepsis. 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 once (dose, indication and expiry date: unknown) (batch/lot number: 7rsl021). On an unknown date, after unknown latency the patient had pseudosepsis. Action taken: unknown. Corrective treatment: not reported for both events outcome: unknown for both events. 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 was completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event for device malfunction additional information was received on 08-dec-2017 and 29-dec-2017 (both information processed together with clock stat date of 08-dec-2017). This case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction. Event of device malfunction was added. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly pharmacovigilance comment: sanofi company comment for follow up dated 08-dec-2017: this case concerns a patient who received synvisc one injection from the recalled lot and had pseudosepsis. As the concerned lot number has been identified to have malfunction by the company, the causal relationship of suspect product cannot be ruled out with the occurrence of adverse events.

• 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: 7186973
• MDR Text Key: 98006708
• Report Number: 2246315-2018-00118
• 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: consumer

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem 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
• Event Location: No Information
• Date Manufacturer Received: 12/08/2017
• 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: 01/12/2018 Patient Sequence Number: 1