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 Diarrhea (1811); Dyspnea (1816); Itching Sensation (1943); Rash (2033); Swelling (2091); No Code Available (3191)

Event Date 10/27/2000

Event Type  Injury  

Event Description

Expulsive diarrhea [diarrhea], eyes swollen shut [eyes swollen], sore throat [sore throat], urinary retention [urinary retention], tachypneic [tachypnoea], trouble breathing [breathing difficult], lip swollen twice their size [lip swelling], swollen face [facial swelling], truncal itching [itching], rash all the way to head [rash all over].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097719 via pharmacist.This case involves an adult patient who experienced expulsive diarrhea, eyes swollen shut, truncal itching, rash all the way to head, sore throat, urinary retention, swollen face, tachypneic, trouble breathing and lip swollen twice their size, with the 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 estrogens conjugated (premarin cd); celecoxib (celebrex); ascorbic acid, retinol, tocopherol (ocuvite); and quinapril hydrochloride (accupril).On (b)(6) 2000, the patient started using hylan g-f 20, sodium hyaluronate at unknown dose and frequency via intra-articular route (lot - unknown) for unknown indication.On (b)(6) 2000 after a latency of 1 day patient experienced expulsive diarrhea (diarrhea), eyes swollen shut (eye swelling), truncal itching (pruritus), rash all the way to head (rash), sore throat (oropharyngeal pain), urinary retention, swollen face (swelling face), tachypneic (tachypnoea), trouble breathing (dyspnoea) and lip swollen twice their size (lip swelling).Patient was hospitalized for these events and they were considered life threatening.Patient received steroid treatment (intervention required).Action taken: unknown for all events.The patient was treated with dextromethorphan hydrobromide, diphenhydramine hydrochloride (benadryl dm), epinephrine, racepinephrine (racepinefrine) and methylprednisolone sodium succinate (solumedrol) for all events.The patient outcome is reported as unknown for all events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc.Batch number: unknown; global ptc number: (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 (corrective and preventive action) was 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 (non-conformances report) 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 if a capa is required.Investigation complete date: 22-jan-2021.Follow up information was received on 11-jan-2021 from the healthcare professional.Comet id number added.No significant information added.Additional information was received on 22-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were 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: 11235874
• MDR Text Key: 231945258
• Report Number: 2246315-2021-00040
• 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: 01/27/2021

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: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• 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): Hospitalization; Life Threatening; Other; Required Intervention