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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Event Description

Device malfunction [device malfunction].Crippling pain [pain].Case narrative: this case is linked to cases (b)(4).(cluster cases) initial information received on 27-jul-2018 regarding an unsolicited valid serious malfunction case received from non-healthcare professional via social media.This case involves an adult patient who experienced device malfunction and crippling pain, while he/she is using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).(latency: unknown).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using synvisc one injection unknown dosage via intra-articular route from (lot - 7rsl021) for product used for unknown indication.Patient reported that he received injection from recalled lot and experienced crippling pain for 2 weeks.No further information provided.Final diagnosis was crippling pain and device malfunction.Corrective treatment: not reported for both events.Outcome: unknown for both events.A product technical report 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.Follow up information received on 31-aug-2018.Global ptc number was added.Text was amended accordingly.

• 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: 7946704
• MDR Text Key: 123961579
• Report Number: 2246315-2018-00669
• 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): Other