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

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

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Blood clot in her lungs [pulmonary embolism].Heel pain.Problems walking.Shortness of breath.Case narrative: initial information received on 07-nov-2018 from united states regarding an unsolicited valid serious case received from a consumer.This case involves a (b)(6) years old female patient who experienced blood clot in her lungs, heel pain, problems walking and shortness of breath, while she was treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included arthritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient received intra-articular synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) (dose, frequency: unknown) for osteoarthritis in both her knees.The first injection of synvisc went well and the patient did not experience any reaction.After receiving the second synvisc injection, patient experienced in heel pain (latency: unknown) and had problems walking (latency: unknown).The patient was instructed to elevate her legs by her orthopedist for heel pain and it went away.Further, she later experienced shortness of breath (latency: unknown) and went to a local er facility, following which she was admitted to the local hospital because of blood clot in her lungs (latency: unknown).It was reported that the patient could not receive her third scheduled dose today because she was still in the hospital.Action taken: drug withdrawn.Corrective treatment: elevate her legs for heel pain; not reported for rest.Outcome: recovered/resolved for heel pain; not recovered/not resolved for blood clot in her lungs; unknown for rest.Seriousness criterion: hospitalization and medically significant for blood clot in her lungs.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 14-nov-2018 for product.Batch number; unknown.The reporter stated that the device complaint resulted in adverse event/handling error.Final investigation complete date: 14-nov-2018 the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.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 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information was received on 14-nov-2018.Global ptc number and ptc results added.Text was 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: 8271329
• MDR Text Key: 133977474
• Report Number: 2246315-2018-00858
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR