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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Type  Injury  

Event Description

Tore her hernia [hernia perforation].Case narrative: initial information was received on 12-sep-2023 regarding a solicited valid serious case from a patient in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6); country: united states.Study title: sanofi patient connection.This case involves a 54 years old female patient who tore her hernia while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] (in right knee) the patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.On an unknown date, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) 48 mg/6ml injection in 10 ml syringe at dose of 6 ml in right knee (lot, expiry date, frequency, route, indication - unknown).Information on batch number was requested.On an unknown date, after unknown latency, the patient tore her hernia (hernia perforation) and she need a walker.This event was leading to disability and was assessed as medically significant.When asked about the prescription information, the patient services representative noted that was what was indicated on the enrollment form.At the time of the report, it was unknown if synvisc-one is continued or not.No additional information at the time of the report.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (tore her hernia).At time of reporting, the outcome was unknown for the event tore her hernia.Reporter causality: not reported.Company causality: not reportable.

Event Description

Tore her hernia [hernia perforation].Case narrative: initial information was received on 12-sep-2023 regarding a solicited valid serious case from a patient in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6); country: united states.Study title: sanofi patient connection.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves a 54 years old female patient who tore her hernia while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] (in right knee).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.On an unknown date, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) 48 mg/6ml injection in 10 ml syringe at dose of 6 ml in right knee (lot, expiry date, frequency, route, indication - unknown).Information on batch number was requested.On an unknown date, after unknown latency, the patient tore her hernia (hernia perforation) and she need a walker.This event was leading to disability and was assessed as medically significant.When asked about the prescription information, the patient services representative noted that was what was indicated on the enrollment form.At the time of the report, it was unknown if synvisc-one is continued or not.No additional information at the time of the report.Action taken: not applicable.Corrective treatment: she need a walker.At time of reporting, the outcome was unknown for the event tore her hernia.Reporter causality: not reported.Company causality: not reportable.Additional information was received on 12-sep-2023 from patient: corrective treatment was added.Text was amended accordingly.

• Brand Name: SYNVISC
• 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: 17774555
• MDR Text Key: 323744195
• Report Number: 2246315-2023-00098
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• 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): Disability; Other
• Patient Sex: Female