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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
Model Number 50653-0006-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 05/21/2022
Event Type  Injury  
Event Description
(b)(6) 2022 the clinic reported the adverse event to orthogenrx who reported it to the genvisc850 call center that a female patient was hospitalized on (b)(6) 2022 for treatment after receiving a genvisc 850 bilateral knee injections on (b)(6) 2022. The patient's medical history includes osteoarthritis with 3 rounds of genvisc850 over many previous years with improvement in mobility/pain. The patient received the 1st bilateral genvisc850 intraarticular knee injection on (b)(6) 2022 for this round of injections. Lidocaine was administered for comfort and omnipaque for the fluoroscopy for the correct placement of the injections. On (b)(6) 2022 the patient went to the hospital with increased pain radiating down her leg. At the hospital the patient had a knee wash-out procedure and was started on iv antibiotics. A culture was done indicating the present of a staph infection. The antibiotics were changed (b)(6) 2022 to vancomycin and a cephalosporin antibiotic. The clinic contact indicated the patient is doing fine. This case is serious and the genvisc850 or the administration procedure including the lidocaine and omnipaque cannot be excluded. (b)(6) 2022 from orthogenrx: lot r-1 finished product release certificate indicates product sterility. (b)(6) 2022 meiji (b)(4) comment: this case has been tagged as serious requiring hospital treatment and longer hospital stay and it cannot be discerned if the genvisc850 or the administration procedure including the lidocaine and omnipaque are responsible. However, 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 orthogenrx comment: genvisc850 lot r-1, consisting of (b)(4) units, was released for distribution on 14-apr-2021. All units were distributed from orthogenrx control by 04-oct-2021. No other reports of infections have been received for this lot. Meiji pharma spain certifies that this batch has been manufactured and analyzed in full compliance (b)(4) the gmp, the local regulation and specifications and requirements of the marketing authorization. Uploaded lot r-1 finished product release certificate indicating product sterility to case file. (b)(6) 2022 the contact updated the ae of this case. 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.
 
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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 Key14697117
MDR Text Key294957883
Report Number3011402886-2022-00002
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier00850653006016
UDI-Public(01)00850653006016(17)240131(10)R1
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 Operator
Device Model Number50653-0006-01
Device Lot NumberR-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2022
Distributor Facility Aware Date05/23/2022
Device Age16 MO
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; OMNIPAQUE
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