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

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

Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Vomiting (2144); Shaking/Tremors (2515); No Code Available (3191)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 20-may-2016: this case concerns a patient who experienced the events of tired, weak, vomiting, nausea, headache, pain and tremor following administration with synvisc one.The events have been assessed as possibly related to the product as there is no evidence suggesting otherwise, however the lack of information regarding the temporal gap between the occurrence of events and the administration of product and patient's clinical course precludes the complete case assessment.

Event Description

Felt tired [tiredness].Weak [weakness].Throw up [vomiting].Had headache [headache].Nausea [nausea].Shaking [shaking].Pain [pain].Diagnosis for use is torn muscle in knee [off label use].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on 12-may-2016 from a patient via health authority of united states (usa-fda with regulatory reference number:mw5061761).This case involves a patient of unknown age and gender (only initials provided) who felt tired, weak, throw up, had headache, nausea, pain and was shaking while receiving treatment with synvisc one for torn muscle in knee (off label use).The patient was allergic to a lot of things but not to chicken.No past drugs or concurrent condition was reported.The concomitant medications were temazepam (restoril), propane, oxycodone, diazepam (valium), furosemide and potassium chloride.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and batch/ lot number: not provided; expiration date: 22-apr-2016) into an unspecified location for torn muscle in knee (off label use) and no cartilage.On (b)(6) 2016, at 08:00 a.M., the patient started experiencing headache.The patient was so very tired and weak, could barely make it into the house.It was reported that the patient got into the chair and all of a sudden, started to throw up.The patient went back to lay down but had to get up again immediately and threw up back and forth until a little after midnight and it finally quit.It was reported that the nausea was back again.The same day, the patient also experienced pain which was 10 on a scale of 1 to 10.The patient was shaking and was so nauseated.Corrective treatment: not reported for tired, weak, throw up, headache, nausea, pain and shaking.Outcome: unknown for tired, weak, throw up, headache, nausea, pain and shaking.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: important medical event (ime) for tired, weak, throw up, headache, nausea, pain and shaking.Pharmacovigilance comment: sanofi company comment dated 20-may-2016: this case concerns a patient who experienced the events of tired, weak, vomiting, nausea, headache, pain and tremor following administration with synvisc one.The events have been assessed as possibly related to the product as there is no evidence suggesting otherwise, however the lack of information regarding the temporal gap between the occurrence of events and the administration of product and patient's clinical course precludes the complete case assessment.

• 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: 5675318
• MDR Text Key: 213234968
• Report Number: 2246315-2016-00080
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/22/2016
• Was Device Available for Evaluation?: No
• 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): Required Intervention; Other