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

Lot Number UNKNOWN

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

Patient Problems Dyspnea (1816); Rash (2033); No Code Available (3191)

Event Date 09/13/2018

Event Type  Injury  

Event Description

Motor skills weren't good/ wasn't even able to squeeze a finger [motor dysfunction], anaphylactic shock [anaphylactic shock], ([blood pressure decreased], [shortness of breath], [vital functions abnormal]), rash [rash].Case narrative: initial information received from united states on 14-sep-2018 regarding an unsolicited valid serious case received from a doctor.This case involves (b)(6) years old female patient who experienced motor skills weren't good/ wasn't even able to squeeze a finger, anaphylactic shock and rash (latency: unknown), while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's medical treatment(s), vaccination(s) and family history were not provided.It was reported that there was nothing in the patient's history in regards to an avian allergy.Concomitant medications included diphenhydramine hydrochloride (benadryl).On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, intra-articular route at an unknown dose (lot - unknown) for unknown indication.On an unknown date, after first injection patient had rash (latency: unknown) which went away with diphenhydramine hydrochloride and patient felt great.It was reported that doctor was thinking about switching her to another product because he was worried about sensitivity but there was nothing in the patient's history in regard to an avian allergy and she had actually raised chickens so there wasn't a lot of concern.It was reported that patient's motor skills were good.They kept her for observation.He states that she was insistent upon getting hylan g-f 20, sodium hyaluronate again because her results were very good after the first injection.On (b)(6) 2018, patient received second injection of hylan g-f 20, sodium hyaluronate.On the same day, 5-10 minutes after the injection, around 12 pm patient went into anaphylactic shock (latency: unknown), had shortness of breath, vitals were dropping, and blood pressure was 90/60.Patient was administered an epinephrine shot and they called 911.Ten-fifteen min, later, the paramedics arrived and gave her another epinephrine shot and they also gave her a salbutamol (albuterol) inhaler and patient's motor skills weren't good and she wasn't even able to squeeze a finger in the office (latency: unknown).Patient's motor skills improved on the way to the ambulance.They were not sure if it was prior or post that the icm contrast (iodinated contrast media) was administered to the patient which was 0.5 cc.Patient was given 10-20 mg of triamcinolone acetonide (kenalog) post hylan g-f 20, sodium hyaluronate.Final diagnosis was anaphylactic shock, motor skills weren't good/ wasn't even able to squeeze a finger and rash.Action taken: unknown.Corrective treatment: triamcinolone acetonide for motor skills weren't good/ wasn't even able to squeeze a finger; triamcinolone acetonide, salbutamol inhaler, epinephrine shot for anaphylactic shock; diphenhydramine hydrochloride for rash.Outcome: recovered / resolved for rash, recovering for motor skills weren't good/ wasn't even able to squeeze a finger; unknown for rest of the events.Seriousness criteria: intervention required for anaphylactic shock, motor skills weren't good/ wasn't even able to squeeze a finger and medically significant for anaphylactic shock.A product technical complaint was initiated on 20-sep-2018 for synvisc.Batch number: unknown global ptc (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa is required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information received on 20-sep-2018.Investigation summary received and ptc results added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC
• 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: 7919874
• MDR Text Key: 122153376
• Report Number: 2246315-2018-00604
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2018
• 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; Required Intervention
• Patient Age: 82 YR