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

Lot Number UNKNOWN

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

Patient Problems Rash (2033); Loss of consciousness (2418)

Event Type  Injury  

Event Description

Passed out for a little over an hour [passed out].Severe rash on both shoulder and neck/ hundreds of small hard pimples but confined to shoulder and neck [pimple-like rash].Case narrative: initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received via patient from health authorities of united states under reference mw5097914.This case involves an unknown age patient who passed out for a little over an hour and rash on both shoulder and neck/ hundreds of small hard pimples but confined to shoulder and neck, while he/she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.No information regarding concomitant medication was provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate at unknown dose once via intra-articular route (with an unknown batch number) for unknown indication.On the same day within minutes after the injection patient passed out for a little over an hour (loss of consciousness) at the doctor's office.This event was assessed as medically significant.After revival, patient went home for the business and on the same evening patient developed severe rash on both shoulders and neck which was being treated with diphenhydramine hydrochloride (benadryl).The rash was like hundreds of small hard pimples but confined to shoulder and neck (dermatitis acneiform).Action taken: not applicable for both events.Corrective treatment: diphenhydramine hydrochloride (benadryl) for dermatitis acneiform; not reported for loss of consciousness.Outcome: unknown for both events a product technical complaint (ptc) was initiated on 14-dec -2020 for synvisc one for unknown batch number and global ptc number: (b)(4).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: 23-dec-2020 follow up information received on 14-dec-2020 from other healthcare professional.Global ptc number was added.Additional information was received on 23-dec-2020 from healthcare professional.Investigational results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 11085656
• MDR Text Key: 230227432
• Report Number: 2246315-2020-00183
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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
• 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