MAUDE Adverse Event Report: SYNVISC; MOZ

Lot Number 9RSP012B

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

Patient Problems Unspecified Infection (1930); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)

Event Date 10/02/2020

Event Type  Injury  

Event Description

Unable to walk and had to use wheelchair to get to the car [unable to walk] infection [joint infection] ([aching (r) knee], [swelling of r knee], [injection site scab]) patient received only 1 injection instead of 3 [inappropriate schedule of product administration].Initial information received on 03-nov-2020 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc.The case is linked to (b)(4) (multiple devices for same patient: left knee) this case involves a (b)(6) male patient who experienced infection (right knee) and not able to walk, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) and patient received only 1 injection instead of 3 (inappropriate schedule of product administration).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 2 ml once (lot - 9rsp012b) in right knee for unknown indication.Patient received only one injection instead of 3 (inappropriate schedule of product administration).On the same day, minutes after the injection patient was not able to walk (gait inability) and had to use a wheelchair to get to the car.Event of gait inability assessed a serious due to disability.Patient was in a lot of pain (arthralgia), right knee had some swelling (joint swelling) and around the injection site there was a scab with surrounded by white (injection site scab) and according to the physician this was an infection (arthritis infective, event assessed as medically significant) (onset: (b)(6) 2020; latency: 0 day).Patient reported that in last couple of days his condition has improved, and he had been able to walk.Action taken: not applicable for inappropriate schedule of product administration; unknown for rest of the events.Corrective treatment: wheelchair for gait inability; not reported for rest of the events.Outcome: not applicable for inappropriate schedule of product administration; recovering for rest of the events.Reporter causality: not reported for all events.Company causality: not reportable for inappropriate schedule of product administration; reportable for rest of the events.A product technical complaint was initiated, and results were pending for the same.

Event Description

Unable to walk and had to use wheelchair to get to the car [unable to walk] infection [joint infection] ([aching (r) knee], [swelling of r knee], [injection site scab]) patient received only 1 injection instead of 3 [inappropriate schedule of product administration].Case narrative: initial information received on 03-nov-2020 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc.The case is linked to 2020sa309671 (multiple devices for same patient: left knee).This case involves a 79 years old male patient who experienced infection (right knee) and not able to walk, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) and patient received only 1 injection instead of 3 (inappropriate schedule of product administration).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 2 ml once (lot - 9rsp012b; expiration date: 31-may-2022) in right knee for unknown indication.Patient received only one injection instead of 3 (inappropriate schedule of product administration).On the same day, minutes after the injection patient was not able to walk (gait inability) and had to use a wheelchair to get to the car.Event of gait inability assessed a serious due to disability.Patient was in a lot of pain (arthralgia), right knee had some swelling (joint swelling) and around the injection site there was a scab with surrounded by white (injection site scab) and according to the physician this was an infection (arthritis infective, event assessed as medically significant) (onset: 02-oct-2020; latency: 0 day).Patient reported that in last couple of days his condition has improved, and he had been able to walk.Action taken: not applicable for inappropriate schedule of product administration; unknown for rest of the events.Corrective treatment: wheelchair for gait inability; not reported for rest of the events.Outcome: not applicable for inappropriate schedule of product administration; recovering for rest of the events.Reporter causality: not reported for all events.Company causality: not reportable for inappropriate schedule of product administration; reportable for rest of the events.A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc lot number 9rsp012b and with global ptc number (b)(4).Adverse event reports with or without lot numbers are continuously monitored, and possible associations with their corresponding product lot were assessed, as part of routine safety surveillance effort to detect safety signals.The production and quality control documentation for lot number 9rsp012b was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for the concerned lot number no capa (corrective and preventive action) was required.This review has not indicated any safety issue.As of 18-nov-2020 there were 12 complaints on file for lot number 9rsp012 and all related sublots, out of which 2 complaints were for lot number 9rsp012b: (2) adverse event reports.Sanofi would continue to monitor complaints as stated in to determine if a capa was required.Final investigation was completed on 20-nov-2020.Follow up information was received on 11-nov-2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 19-nov-2020 and 20-nov-2020 (both significant, case processed with clock start date of 19-nov-2020) from healthcare professional.Investigational results and expiration date for suspected lot number were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• MDR Report Key: 10799681
• MDR Text Key: 217092218
• Report Number: 2246315-2020-00157
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Lot Number: 9RSP012B
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability