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

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

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Nausea (1970); Pneumonia (2011); Blurred Vision (2137); Dizziness (2194); No Code Available (3191)

Event Date 10/24/2020

Event Type  Injury  

Event Description

Diagnosed with ground glass pneumonia [pneumonia] ([exhaustion], [shortness of breath]). Could not work or drive [inability to work]. Could not work or drive [impaired driving ability]. Trying to read the paperwork and noted blurred vision [blurred vision]. Developed a headache and was treated for migraine [migraine headache]. Labs showed elevated d-dimer [fibrin d dimer increased]. Super sick [sickness]. Intense headache [headache]. Dizziness [dizziness]. Nausea [nausea]. Right arm and lips felt tingly [tingling lips]. Right arm and lips felt tingly [paraesthesia upper limb]. Synvisc one given for post knee surgery pain [product use in unapproved indication]. Case narrative: initial information from united states received on 24-nov-2020 regarding an unsolicited valid serious case from a patient via call center. This case involves a (b)(6) years old female patient who was diagnosed with ground glass pneumonia, could not work or drive, trying to read the paperwork and noted blurred vision, developed a headache and was treated for migraine, labs showed elevated d-dimer, super sick, intense headache, dizziness, nausea, right arm and lips felt tingly, while using the medical device hylan g-f 20, sodium hyaluronate (synvisc one) for post knee surgery pain. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had used this product for the first time. On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection once (dose, route and batch number unknown) for post knee surgery pain (product use in unapproved indication). On the same day in less than 10 minutes after her injection her right arm (paraesthesia) and lips felt tingly (paraesthesia oral). On the same day, patient was trying to read the paperwork from hcp (healthcare professional) and noted blurred vision (vision blurred). The patient developed a headache then went to ed (emergency department) where she was treated for migraine (migraine headache). On (b)(6) 2020, the next day after latency of 1 day, patient was super sick (illness), had intense headache (headache), dizziness, nausea. Patient could not work or drive (impaired work ability and impaired driving ability; seriousness criteria: disability). On an unknown date in 2020, after unknown latency, patient felt exhausted (fatigue) and had shortness of breath (dyspnoea). With further follow-up from hcp her labs showed elevated d-dimer (fibrin d dimer increased) and ct (computerized tomogram) with contrast was done (results not reported). She was diagnosed with ground glass pneumonia (pneumonia) (seriousness criteria: medically significant) (onset: 2020 and latency unknown) and was started on an antibiotic twice to treat it. The patient asked if there was any information on similar adverse events and treatment. Action taken: not applicable for all events. Corrective treatment: started on an antibiotic twice to treat pneumonia; unspecified for migraine headache; not reported for rest events. Outcome: not applicable for product use in unapproved indication; unknown for all other events.

• 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: 10913329
• MDR Text Key: 219954962
• Report Number: 2246315-2020-00161
• 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,Followup,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• 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: 11/27/2020 Patient Sequence Number: 1