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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance 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 safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.

Event Description

Pretty bad allergic reaction [allergic reaction].Case narrative: this case is cross referenced with case: (b)(4) cluster).This unsolicited case from united states was received on 10-may-2018 from a non-healthcare professional.This case involves a female patient of unknown age who received treatment with synvisc one and later after unknown latency had a pretty bad allergic reaction.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown).On an unknown date, after unknown latency the patient had a pretty bad allergic reaction.Corrective treatment: knee surgery; outcome: unknown.Seriousness criteria: required intervention.A product technical complaint was initiated on (b)(6) 2018 for synvisc one, batch number "unknown", global ptc number "(b)(4)".The reporter stated that the device "caused a pretty bad allergic reaction" and it resulted in hyper-sensitivity.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance 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 safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information received on (b)(6) 2018.Global ptc number and results were received.Text amended accordingly.Upon internal review on 27-nov-2018, the following changes were made in the case, this batch was identified in context of affiliates requests and concerns the field reporter causality which was amended from not reported to related in context of unsolicited report.

• Brand Name: SYNVISC ONE
• 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: 8200890
• MDR Text Key: 131585616
• Report Number: 2246315-2018-00837
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Required Intervention