MAUDE Adverse Event Report: MEIJI PHARMA SPAIN S.A GENVISC850 ACID, HYALURONIC, INTRAARTICULAR

Lot Number R-1

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

Patient Problem Bacterial Infection (1735)

Event Date 05/23/2022

Event Type  Injury  

Event Description

(b)(6) 2022 the clinic reported an adverse event to orthogenrx who reported it to the genvisc850 call center that a male patient was seen in the clinic on (b)(6) 2022 for symptoms of increased pain and swelling after receiving a genvisc 850 right knee injection on (b)(6) 2022. The patient's medical history includes osteoarthritis. The patient received a genvisc850 intraarticular right knee injection on (b)(6) 2022. Lidocaine was administered for comfort and omnipaque for the fluoroscopy for the correct placement of the injection. On (b)(6) 2022 the patient was seen in the clinic for complaints of increased pain and swelling in the right knee. An aspiration was done and the fluid was sent to be cultured. The results of the culture are unknown at this time. The clinic contact indicated the patient is uncomfortable. Until more information is known the genvisc850 or the administration procedure including the lidocaine and omnipaque cannot be excluded in the ae. (b)(6) 2022 from orthogenrx: lot r-1 finished product release certificate indicates product sterility. (b)(6) 2022 meiji pharma (b)(4) comment: this case has been tagged as non-serious requiring medical follow-up and the result of the culture, and it cannot be discerned if the genvisc850 or the administration procedure including the lidocaine and omnipaque are responsible. Based on the temporal sequence, the causal role of sodium hyaluronate in the event developed cannot be ruled out as well as the omnipaque and lidocaine used and the administration procedure. The lack of issues in the batch used and the lack of specific information on the antiseptic approach use might pinpoints to the injection procedure followed. (b)(6) 2022 the contact updated the ae of this case. On (b)(6) 2022 the culture results were positive for staph infection. The patient was admitted to the hospital through the er and underwent a knee washout procedure and is being treated with iv antibiotics. He said they no longer suspect genvisc850 was contributory to the ae due to another incident unrelated to genvisc850. They believe the cause of this ae of infection likely to be the multiuse vials of lidocaine and omnipaque. They did not retain the multiuse vials of lidocaine and omnipaque so no cultures of these products were done. He is reporting the adverse events to these product companies as well. (b)(6) 2022 the lot r-1 finished product release certificate indicates product sterility for the genvisc850.

• Brand Name: GENVISC850
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): MEIJI PHARMA SPAIN S.A; avda. de madrid, 94; 28802 alcalá de henares; madrid, ; SP
• MDR Report Key: 14697271
• Report Number: 3011402886-2022-00003
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/15/2022,05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: R-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/23/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sex: Male
• Patient Treatment(s): LIDOCAINE
• Patient Outcome(s): Required Intervention; Hospitalization