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

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

Patient Problems Bacterial Infection (1735); Fever (1858); Inflammation (1932); Therapeutic Response, Decreased (2271); Arthralgia (2355); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Bacterial contamination in her blood and feels it settled in her back/bacterial blood infection/contaminated with a bacteria from synvisc/believed to be contaminated with the 3rd injection [bacteremia] ([fever]); had water, pain and inflammation that settled in her back [back pain (without radiation)].Abnormal pap smear [pap smear abnormal]; abnormal biopsy of her vagina [biopsy vagina abnormal]; coughing [coughing]; had water, pain and inflammation that settled in her back [water retention] ; had water, pain and inflammation that settled in her back [inflammation] ; lifestyle and quality of life has drastically changed since this has happened/out of work for 3 months [impaired quality of life] ; couldn't walk [unable to walk]; knee pain at night when resting [knee pain]; no significant improvement [subtherapeutic response].Case narrative: initial information received on 12-aug-2019 regarding an unsolicited valid serious case received from a patient from united states.This case involves a (b)(6) years old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc) and after unknown latency bacterial contamination in her blood and feels it settled in her back/bacterial blood infection/contaminated with a bacteria from synvisc/believed to be contaminated with the 3rd injection, couldn't walk, abnormal pap smear, abnormal biopsy of her vagina, coughing, had water, pain and inflammation that settled in her back, lifestyle and quality of life has drastically changed since this has happened/out of work for 3 months, knee pain at night when resting and no significant improvement.The patient's past medical history included herniated disc and a titanium cage placed about 20 years ago.Patient had no cartilage in her right knee.Patient was on high blood pressure medication.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date in (b)(6) 2018, the patient initiated treatment with intra-articular hylan g-f 20 sodium hyaluronate injection, at a dose of 2 ml, thrice (lot - unk) for osteoarthritis in the right knee.Information regarding batch number was requested.Patient had second injection in (b)(6) 2018 or (b)(6) 2019 (exact date not provided) and third injection in (b)(6) 2019.On the next day of injection, patient woke up sick with a fever of 103.On an unknown date in (b)(6) 2019, patient was hospitalized for 10 days with a diagnosis of bacterial contamination in her blood and fever and felt it settled in her back where she had a herniated disc and a titanium cage placed about 20 years ago.Th event was assessed as serious with hospitalization and medically significant as seriousness criteria.Patient's lifestyle and quality of life had drastically changed since this has happened and couldn't walk.Patient was discharged in (b)(6) 2019 and sent home with a picc line and needed six weeks of antibiotics and pt (physical therapy) every day.Patient was not having really any knee pain, redness or swelling after her injections but no significant improvement.On an unknown date in 2019, patient could not walk and had knee pain at night when resting, had water, pain and inflammation that settled in her back that the infectious disease doctor felt was related to her hylan g-f 20 sodium hyaluronate injections since she had not had any dental work or anything else to cause the bacterial blood infection and 'lead such a healthy lifestyle'.Also reported that the patient's magnetic resonance imaging (mri) on her back had shown improvement and she had physical therapy.On an unknown date in 2019, patient had an abnormal pap smear and an abnormal biopsy of her vagina which she attributed to the contamination of the synvisc.Also reported that patient was coughing (onset date: unknown) during the conversation.Patient was out of work for 3 months and did not return until (b)(6) 2019.Action taken: not applicable for all events.Corrective treatment: patient received antibiotics for bacterial infection, physical therapy for back pain; not reported for other events.Outcome: not applicable for no significant improvement; unknown for rest all events.A pharmaceutical technical complaint (ptc) was initiated on 20-aug-2019 for synvisc; lot number: unknown, with global ptc number: (b)(4).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 monitored adverse event reports with or without lot numbers, and assessed 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.Final investigation was completed on 20-aug-2019.Additional information was received on 20-aug-2019.Global ptc number and results were added.Text was 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: 8939227
• MDR Text Key: 160869967
• Report Number: 2246315-2019-00219
• 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: consumer
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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