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

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

Patient Problems Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 06/01/2018

Event Type  Injury  

Event Description

Swelling/knee swelled to the point that is was uncomfortable [knee swelling]; pain [pain]; additional synvisc-one injection about 1 month [device use error]; receiving injection in the same knee without immediate pain relief [subtherapeutic response]; avian allergy due to extent of swelling [hypersensitivity reaction].Case narrative: based on the additional information received on 01-aug-2018, the case that was initially assessed as non-serious has been updated to serious as event of swelling/swelled to the point that is was uncomfortable with seriousness criteria as intervention required.Initial information received on 28-jun-2018 regarding an unsolicited valid non-serious case from united states was received from other non-health care professional.This case involves an elderly female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and after unknown latency experienced swelling/swelled to the point that is was uncomfortable and pain, additional synvisc-one injection about 1 month, receiving injection in the same knee without immediate pain relief and avian allergy due to extent of swelling added.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, the patient received intra articular hylan g-f 20, sodium hyaluronate injection, at a dose 6 ml, once for osteoarthritis.On an unknown date in (b)(6) 2018, after unknown latency, patient experienced swelling and pain for 1 week after the injection.The clinical director was requesting replacement of that synvisc- one injection so the patient could be re-injected on the (b)(6) 2018.Patient who received an additional synvisc-one injection about 1 month after receiving it in the same knee without immediate pain relief.It was reported that they had previously received synvisc-one in a knee and had no pain relief immediately so got another synvisc-one injection in that same knee about 1 month later and the knee swelled to the point that is was uncomfortable and needed a steroid injection.Hcp thought patient may have an avian allergy due to extent of swelling.This most recent injection was about 1 month ago; reporter got an email from practice today and then spoke with nurse there about this.Caller asks if it is possible to request reimbursement as patient had reaction; referred to hcp and advised price primarily depends on insurance, prior authorization.Final diagnosis was pain and swelling/swelled to the point that is was uncomfortable, additional synvisc-one injection about 1 month, receiving injection in the same knee without immediate pain relief and avian allergy due to extent of swelling.Corrective treatment: steroids for pain and not reported for rest of the events the patient outcome is reported as unknown for pain and swelling/swelled to the point that is was uncomfortable and avian allergy due to extent of swelling.A product technical complaint (ptc) was initiated on 02-jul-2018 for "synvisc one".Batch number; unknown global ptc number: (b)(4).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 is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information received from 02-jul-2018.Global ptc number & ptc results were added.Text was amended accordingly.Additional information received from 01-aug-2018.Additional events of additional synvisc-one injection about 1 month, receiving injection in the same knee without immediate pain relief and avian allergy due to extent of swelling added.Verbatim updated for swelling to swelling/swelled to the point that is was uncomfortable.Case upgraded to serious.Clinical course and text amended accordingly.

• 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: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8389639
• MDR Text Key: 137804116
• Report Number: 2246315-2018-00865
• 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
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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