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U.S. Department of Health and Human Services

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

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MEIJI PHARMA SPAIN S.A GENVISC850 ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameGENVISC850
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
MEIJI PHARMA SPAIN S.A
avda. de madrid, 94
28802 alcalá de henares
madrid,
SP
MDR Report Key14697271
MDR Text Key294946171
Report Number3011402886-2022-00003
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberR-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2022
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/15/2022 Patient Sequence Number: 1
Treatment
LIDOCAINE
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