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 Problem Bacterial Infection (1735)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 12-dec-2017 from a nurse. This case concerns a (b)(6) year old patient (gender unspecified) who received treatment with synvisc one and later few days after starting treatment, patient did have a reaction, also; device malfunction was identified for the reported lot number. No medical history, past drug, concomitant medication or concurrent condition was provided. On an unknown date in (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection (dose and indication: unknown) (batch/lot number: 7rsl021; expiry date: unknown). On an unknown date in 2017, (unknown latency after starting treatment), the patient did have a reaction, but nurse did not elaborate. Patient due for another injection in the end of december. Corrective treatment: not reported for both. Outcome: unknown for both. A pharmaceutical technical complaint (ptc) was initiated and results were pending for same. 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 is completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event of device malfunction pharmacovigilance comment: sanofi company comment dated 12-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced unspecified reaction. Although exact event dates are not reported; however, based on reported information, a temporal relationship cannot be ruled out with the product administration. In addition, the concerned lot number has been identified to have malfunction by the company; hence, the causal relationship of the events to the product cannot be excluded.

• 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: 7170825
• MDR Text Key: 97803241
• Report Number: 2246315-2017-00408
• 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

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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/12/2017
• 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: 01/07/2018 Patient Sequence Number: 1