MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 12/08/2017

Event Type  Injury  

Event Description

Pain [pain], swelling [swelling], device malfunction [device malfunction].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on 27-feb-2018 from a health authority (fda) via healthcare professional.This case involves a patient (demographics: not provided) who received treatment with synvisc one and the after unknown latency had pain and swelling.Also, device malfunction was identified for the reported lot number.No past drugs, medical history, concomitant medication or concurrent condition was reported.On an unknown date, the patient received treatment with intra-articular synvisc one injection (dose, indication and frequency: not provided) (route, batch/ lot number: 7rsl021and expiration date: unknown).On (b)(6) 2017, after unknown latency, the patient had continued pain and swelling after injection.Corrective treatment: not reported for all the events outcome: unknown for all the events 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 criteria: medically significant for all the events.Pharmacovigilance comment: sanofi company comment dated dated 27-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain and swelling.Although a significant temporal relationship cannot be established with the product administration, but causal role cannot be denied as the concerned lot number has been identified to have malfunction by the company.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 7331036
• MDR Text Key: 205504133
• Report Number: 2246315-2018-00373
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other