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

Lot Number CRSP005A

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

Patient Problems Erythema (1840); Arthralgia (2355); Angioedema (4536); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 09-aug-2022: this case involves an unknown age female patient who had aspirated the injection site where she had redness, swelling, burning and clinic had expired doses and they are trying to get credit for the medication due to the reactions while being treated with hylan g-f 20, sodium hyaluronate [synvisc].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Aspirated the injection site [arthrocentesis].Injection site joint effusion [injection site joint effusion].Aspirated the injection site where she had redness [injection site joint erythema].Aspirated the injection site where she had swelling [injection site joint swelling].Aspirated the injection site where she had burning [injection site joint pain] ([expired product administered].Case narrative: initial information received on 04-aug-2022 from united sates regarding an unsolicited valid serious case received from an other health professional.This case involves an unknown age female patient who had aspirated the injection site where she had redness, swelling, burning and clinic had expired doses and they are trying to get credit for the medication due to the reactions while being treated with 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 (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection (with an unknown batch number, expiry date, strength, dose, route, frequency) for product used for unknown indication.On (b)(6) 2022 after a latency of same day she stated that the clinic has expired doses and they are trying to get credit for the medication due to the reactions (expired product administered).She had redness (injection site joint erythema), swelling (injection site joint swelling) and burning (injection site joint pain) they did not do the second injection because the patient refused.On (b)(6) 2022 after a latency of 4 days she called the office and felt that she was having a reaction so they had her come in and they aspirated the injection site (aspiration joint) (injection site joint effusion).They had two doses left in the kit.The md gave her a prescription for celebrex on (b)(6) 2022.On (b)(6) 2022 they did bilateral steroids and steroid injection the week of (b)(6) 2022.Then patient will be seen one week later.No further information provided by reporter.Action taken: not applicable for the event expired product administered and drug withdrawn for rest of the events.Corrective treatment: celebrex and steroid injection for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant and intervention required for aspiration, intervention required for rest all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Aspirated the injection site [arthrocentesis] injection site joint effusion [injection site joint effusion] ([injection site joint erythema], [injection site joint swelling], [injection site joint pain], [expired product administered]).Case narrative: this case is linked to case id (b)(4) (cluster case).Initial information received on 04-aug-2022 from united sates regarding an unsolicited valid serious case received from an other health professional.This case involves an unknown age female patient who had aspirated the injection site and injection site joint effusion with the use of medical device while being treated with 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 (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection (batch number: crsp005a, expiry date: 28-feb-2025, strength: 16mg/2ml) (unknown: dose, route, frequency) for product used for unknown indication.On (b)(6) 2022 after a latency of same day she stated that the clinic has expired doses and they are trying to get credit for the medication due to the reactions (expired product administered).She had redness (injection site joint erythema), swelling (injection site joint swelling) and burning (injection site joint pain) they did not do the second injection because the patient refused.On (b)(6) 2022 after a latency of 4 days she called the office and felt that she was having a reaction so they had her come in and they aspirated the injection site (aspiration joint) (injection site joint effusion).They had two doses left in the kit.The md gave her a prescription for celebrex on (b)(6) 2022.On (b)(6) 2022 they did bilateral steroids and steroid injection the week of (b)(6) 2022.Then patient will be seen one week later.No further information provided by reporter.Action taken: drug withdrawn for all the events.Corrective treatment: celebrex and steroid injection for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant and intervention required for aspiration, intervention required for rest all the events.A product technical complaint (ptc) was initiated on 04-aug-2022 for synvisc (lot/batch number: crsp005a and expiry date: 28-feb-2025) with global ptc number: (b)(4).The sample status of the ptc was not received and the ptc stated: synvisc was manufactured on 23mar2022 yielding (b)(4) kits (3 syringes per kit).The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.There were no in-process issues noted during the process.Furthermore, no associated non conformances were noted.Customer sample was not available for evaluation.Trend analysis: this was the second complaint for batch crsp005a.Comet (b)(4) dissociated plunger comet (b)(4) pv event based on investigation, no capa required.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without product 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 will continue to monitor adverse events and perform trend analysis on a periodic basis.The final investigation was completed on 03-oct-2022 with summarized conclusion as no assessment possible.Additional information was received on 03-oct-2022 from the quality department.Ptc details, strength, batch number and expiry date was added.

• 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: 15238482
• MDR Text Key: 298032163
• Report Number: 2246315-2022-00097
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSP005A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Other; Required Intervention
• Patient Sex: Female