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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Could not walk at all [walking difficulty].Terrible pain [pain].Case narrative: initial information received on 27-jul-2018 regarding an unsolicited valid serious malfunction case from united states received from a patient via social media.This case is linked to cases (b)(4) (cluster).This case involves adult patient who could not walk at all, while he/she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].A device malfunction was noted in the reported batch number.The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient took intra-articular synvisc one injection dosage unknown (with batch number 7rsl021; expiration date: unknown).On an unknown date after an unknown latency patient reported he/ she could not walk at all.Patient took pain killers and prednisone for the same and had to literally use a chair at home to move around.A device malfunction was noted in the reported batch number.Final diagnosis was could not walk at all and device malfunction.Corrective treatment: prednisone and pain killer could not walk at all and terrible pain.Outcome: unknown for all events.Seriousness criteria: intervention required for all events.A pharmaceutical technical complaint was initiated with (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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Follow up information received on 24-aug-2018.No new information was received.Follow up was received on 31-aug-2018.Global ptc number was added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7946602
• MDR Text Key: 123066069
• Report Number: 2246315-2018-00667
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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; Disability