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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

Injured as a result of the use of synvisc-one [injury associated with device] ([device malfunction]).Case narrative: initial information received on 04-mar-2020 regarding an unsolicited valid serious case received from a lawyer and healthcare professional.This case involves a patient of unknown demographics who was injured as a result of the use of hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was noted in the reported batch number.The case is linked to (b)(4) (duplicate).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 hylan g-f 20, sodium hyaluronate (formulation, dose, indication, frequency: unknown) (lot - 7rsl021) for product used for unknown indication.On an unknown date, after unknown latency, patient had injury due to hylan g-f 20, sodium hyaluronate (medically significant).Action taken: not applicable.It was not reported if the patient received a corrective treatment.Outcome: unknown.A product technical compliant was initiated on 16-dec-2019 for synvisc one with batch number: 7rsl021 and global ptc number: (b)(4).Investigation was initiated for increase number of reported aes.An investigation was initiated as a result of an unexpected increase in the number of labeled 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.An investigation ((b)(4)) was performed and capas were identified with timelines for implementation of these capas.Investigation complete date: 04-mar-2020.

Event Description

Injured as a result of the use of synvisc-one [injury associated with device] device malfunction [device malfunction] case narrative: initial information was received from united states on 04-mar-2020 regarding an unsolicited valid serious case from a lawyer and healthcare professional.This case involves a patient of unknown demographics who was injured as a result of the use of hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was noted in the reported batch number.The case is linked to (b)(4) (duplicate).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (formulation, dose, indication, frequency: unknown) (lot - 7rsl021; expiration date: unknown) for unknown indication.On an unknown date, after unknown latency, patient had injury due to hylan g-f 20, sodium hyaluronate (medically significant).Action taken: not applicable for both events.It was not reported if the patient received a corrective treatment for both events.Outcome: unknown for both events.A product technical compliant was initiated for synvisc one with batch number: 7rsl021 and global ptc number: (b)(4).Investigation was initiated for increase number of reported aes.An investigation was initiated as a result of an unexpected increase in the number of labeled 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.An investigation (b)(4) was performed and capas were identified with timelines for implementation of these capas.Follow up information received on 04-mar-2020.No significant information follow up was received on 24-jun-2020 from other healthcare professional: global ptc number was updated to (b)(4).Upon internal review, country of incidence was added in narrative.Device malfunction was updated to main diagnosis from previously captured symptom of injured as a result of the use of synvisc-one.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 9842412
• MDR Text Key: 196575499
• Report Number: 2246315-2020-00048
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention