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

Lot Number UNKNOWN

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Has been hurting so bad, it was more painful than what patient was normally experiencing [pain aggravated].Case narrative: initial information received on (b)(6) 2021, from (b)(6) regarding an unsolicited valid social media serious case received from a consumer/non-hcp.This case involves adult patient who has been hurting so bad, it was more painful than what patient was normally experiencing while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, batch number, route, indication, frequency: unknown).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had been hurting and was so bad.It was more painful than what patient was normally experiencing (pain) (intervention required) and received cortisone to ease the pain.Action taken: unknown.Corrective treatment: cortisone for pain.At time of reporting, the outcome was unknown for the event has been hurting so bad, it was more painful than what patient was normally experiencing.

Event Description

Cramps [cramps].Couldn't stand up [difficulty in standing].Must be allergic [drug hypersensitivity] ([burning sensation], [arthralgia aggravated]).Case narrative: initial information received on 10-dec-2021 from canada regarding an unsolicited valid social media serious case received from a consumer/non-hcp.This case involves adult patient who experienced couldn't stand up, had cramps and must be allergic while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included knee pain.The patient's past medical treatment(s) included cortisone injection, that the patient used for 2 years, every 4 to 5 months.The patient's past vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate [synvisc] (strength, form, dosage, frequency, route, batch number, expiration date and indication: unknown).The patient's doctor decided to start the medication and 1 day later unfortunately, an incredible pain went through the patient's knee, a burning like there were 20 needles in the patient's knee (burning sensation), cramps (muscle spasms),the patient could not stand up (dysstasia), it was unbearable but the patient endured it for 24 hrs and mentioned that it was so much more painful than the knee pain the patient had before calling the doctor urgently, who gave him a shot of cortisone to relieve the pain and mentioned that may be the patient was allergic (drug hypersensitivity).First time product used : yes.Action taken: not applicable.The patient was treated with cortisone for all the events.At time of reporting, the outcome was unknown for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc.Batch number: unknown; comet compliant id number: (b)(4).Sample status: not available 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 is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Final investigation complete date was 14-jan-2022.No safety issues were indicated in this review.Based on the information received on 14-jan-2022 from the non-healthcare professional, case (b)(4) (to be deleted) was identified to be duplicate of case (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in the current case.Text 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: 13087476
• MDR Text Key: 285174387
• Report Number: 2246315-2021-00183
• 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: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• 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): Required Intervention
• Patient Sex: Female