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

Lot Number UNKNOWN

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

Patient Problems Death (1802); Nausea (1970)

Event Date 01/01/1998

Event Type  Death  

Event Description

Found dead at 10:10 pm [found dead (cause undetermined)].Nausea [nausea].Case narrative: initial information from united states received regarding an unsolicited valid serious case received from a nurse via the health authority (reference number: mw50597772).This case involves an unknown age patient who had nausea and was found dead at 10:10 pm, after use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included digoxin (lanoxin); furosemide (lasix); potassium; glyceryl trinitrate (nitrodur); latanoprost (xalantan); dextropropoxyphene napsilate, paracetamol (darvocet); lisinopril (zestril); acetylsalicylic acid (asa); allopurinol (zyloprim); docusate sodium (colace); nabumetone (relafen) and zaroxalen.On an unknown date 1998, the patient started using hylan g-f 20, sodium hyaluronate (unknown dose and frequency) via intra-articular route (lot: reported as h714 (confirmed as invalid); expiry date: 01-aug-1999) for unknown indication.On an unknown date in 1998, patient received the second injection of hylan g-f 20, sodium hyaluronate at 01:45 pm.The patient returned to the nursing home at 4 pm complaining of nausea (not an unusual complaint as per reporter).At 08:30 pm, the checkup was done, and patient complained of nausea.It was reported that the patient was found dead at 10:10 pm (death).This event was assessed as medically significant and was leading to death.It was unknown if an autopsy was done.The cause of death was unknown.Action taken: not applicable for both events.It was not reported if the patient received a corrective treatment.Outcome: fatal for death and unknown for nausea.A product technical complaint (ptc) was initiated for synvisc for unknown batch number and global ptc number: 100085440 the product lot number was not provided; therefore, a batch record review was not possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 09-dec-2020.Additional information was received on 15-dec-2020 from healthcare professional (genzyme event management group).Information about batch number updated.Upon internal review investigation summary was added.Clinical course updated.Text 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: 11035242
• MDR Text Key: 222273863
• Report Number: 2246315-2020-00172
• 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
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/01/1999
• Device Lot Number: UNKNOWN
• 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
• Treatment: ASA (ASA),UNKNOWN; COLACE (DOCUSATE SODIUM),UNKNOWN; DARVOCET [DEXTROPROPOXYPHENE NAPSILATE,PARACETAMOL; LANOXIN (DIGOXIN),UNKNOWN; LASIX [FUROSEMIDE] (FUROSEMIDE),UNKNOWN; NITRODUR (GLYCERYL TRINITRATE),UNKNOWN; POTASSIUM (POTASSIUM),UNKNOWN; RELAFEN (NABUMETONE),UNKNOWN; XALANTAN (LATANOPROST),UNKNOWN; ZESTRIL (LISINOPRIL),UNKNOWN; ZYLOPRIM (ALLOPURINOL),UNKNOWN
• Patient Outcome(s): Death; Other