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 Erythema (1840); Pain (1994); Swelling (2091)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

Based on additional information received on 22-nov- 2017, this case initially considered as non-serious was upgraded to serious (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 17-nov-2017 from a physician.This case concerns a patient of unknown age and gender who received treatment with synvisc one and later after unknown latency had swelling, pain and redness at injection site, also, device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (batch/lot number: 7rsl021; dose, indication, expiry date: unknown).On an unknown date in (b)(6) 2017, after unknown latency, the patient had swelling, pain and redness at the injection site.Corrective treatment: not reported for all the events outcome: unknown for all the events a pharmaceutical technical complaint (ptc) was initiated and 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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event of device malfunction additional information was received on 22-nov-2017.Global ptc number was added.Additional event of device malfunction was added with details.Seriousness criterion was added.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 22-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced swelling, redness and pain at injection site.A temporal relationship cannot be established with the product administration since event onset date and product therapy details are unknown.However, 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: 7144419
• MDR Text Key: 96243212
• Report Number: 2246315-2017-00343
• 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: health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/17/2017

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: 11/22/2017
• Initial Date FDA Received: 12/22/2017
• 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