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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
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.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key11001675
MDR Text Key221479959
Report Number2246315-2020-00167
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
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 Received12/14/2020
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
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