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

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

Patient Problems Fever (1858); Headache (1880); Chills (2191); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 11-dec-2020: this case involves a female patient who required intervention after terrible reaction, including a fever of 102. 1f, chills, headache, and just generally felt awful. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, therapy details, any family history and any relevant medical history of patient, any concurrent conditions precludes comprehensive case assessment.

Event Description

Terrible reaction, including a fever of 102. 1f, chills, headache, and just generally felt awful/worse again (recurrent) [chills worsened] terrible reaction, including a fever of 102. 1f, chills, headache, and just generally felt awful/worse again (recurrent) [fever] ([condition worsened]) terrible reaction, including a fever of 102. 1f, chills, headache, and just generally felt awful/worse again (recurrent) [headache aggravated] terrible reaction, including a fever of 102. 1f, chills, headache, and just generally felt awful/worse again (recurrent) [feels awful] ([condition worsened]) inflammation markers are high [inflammatory marker increased] her knee hurt to touch, was swollen, stiff, and felt like it was in a vice and continuing to squeeze [joint tenderness] her knee hurt to touch, was swollen, stiff, and felt like it was in a vice and continuing to squeeze [knee swelling] her knee hurt to touch, was swollen, stiff, and felt like it was in a vice and continuing to squeeze [stiff knees] her knee hurt to touch, was swollen, stiff, and felt like it was in a vice and continuing to squeeze [effusion of knee]. Case narrative: initial information received on 08-dec-2020 from united states regarding an unsolicited valid serious case received from a patient. This case involves a (b)(6) female patient who experienced terrible reaction, including a fever of 102. 1f, chills, headache, and just generally felt awful/worse again (recurrent), inflammation markers are high, her knee hurt to touch, was swollen, stiff, and felt like it was in a vice and continuing to squeeze, with the use of medical device 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 (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, solution for injection, dosage 6 ml once, (lot number: unknown) for osteoarthritis. The information regarding batch number was requested. On (b)(6) 2020, after latency of 24 hours, the patient had terrible reaction, including a fever of 102. 1f, chills, headache, and just generally felt awful (recurrent) (chills, pyrexia, headache, feeling abnormal; seriousness criteria: intervention required for all events). The patient called her healthcare professional (hcp) who wanted to see her, however, because she had a fever, she could not go into the hcp office. Because of this, the patient took her own prednisone which helped her to feel better. But once she stopped the prednisone, she got worse again (condition aggravated). The patient took paracetamol (tylenol) to get her fever down, so she could get in to see her hcp. The hcp who did her blood work that showed that the inflammation markers were high (inflammatory marker increased). The hcp put the patient back on prednisone and she got better again for another 5-6 days. Once the prednisone was done, the patient's symptoms returned. On an unknown date in 2020, after unknown latency, her knee was hurt to touch, was swollen, stiff, and felt like it was in a vice and continuing to squeeze (arthralgia, joint swelling, joint stiffness, joint effusion). The patient reported that the hcp was not much help for her and everything she found out about hylan g-f 20, sodium hyaluronate, she read online. The patient asked if the side effects she was experiencing was the side effects of hylan g-f 20, sodium hyaluronate and if so, how long they would last and how it should be treated, asked if synvisc was recalled in 2017. Action taken- not applicable for all events. The patient was treated with prednisone for pyrexia, headache, chills and feeling abnormal and paracetamol (tylenol) for pyrexia. The patient outcome is reported as unknown for all events. A product technical complaint was initiated and results were pending for the same.

• 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: 11001675
• MDR Text Key: 221479959
• Report Number: 2246315-2020-00167
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 12/14/2020 Patient Sequence Number: 1