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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 03/31/2022
Event Type  Injury  
Event Description
The genvisc 850 call center was notified by an (b)(6) employee that an hcp reported a male patient was admitted to a hospital and diagnosed with a right knee intra-articular joint infection. The ae assessor spoke with the hcp (who gave the injection) for the investigation of the complaint of the right knee intra-articular joint infection on (b)(6) 2022 after a third right knee intra-articular genvisc 850 injection on (b)(6) 2022. The patient's medical history includes osteoarthritis, diabetes, gout, copd, chronic low back pain, coronary artery disease, atrial fibrillation, bladder cancer with previous injections of genvisc 850 with no complaints. The patient received right knee intra-articular genvisc 850 injections with the first on (b)(6) 2022, second on (b)(6) 2022 and third on (b)(6) 2022. The hcp's medical assistant did the preparation which included preparing the patient's knee and the syringes that held the lidocaine, omnipaque and genvisc850. The hcp could not provide details of how the ma prepared. The hcp provided the injections. The patient received the left knee intra-articular genvisc 850 injections with the first on (b)(6) 2022, second on (b)(6) 2022 and third on (b)(6) 2022. When the patient received the third left knee intra-articular genvisc 850 injection on (b)(6) 2022, the patient did not complain about the right knee. On (b)(6) 2022 the patient was admitted to the hospital and diagnosed with a right knee intra-articular joint infection. The patient at the hospital was taken to the or for a knee wash out procedure and is currently on iv antibiotics and recovering. The culture grew out staph and serratia. Staph is a bacteria found on human skin, nose, under arm, groin etc. Serratia is a bacteria found on water surfaces such as "toilet bowl, shower stall, bathtub and pet's water dish as a pink film" as well as "dust in the feces of animals and humans". It is also found in the soil. The hcp said it is unknown what the patient did after leaving the clinic, whether he gardens, and whether the patient has any pets. No cultures were done at the clinic. The causal role of the genvisc 850 and/or the administration procedure for the right knee infection, a serious case, cannot be excluded due to the temporal sequence of the events. Meiji pharma (b)(4) comment: 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 and/or the administration procedure in the right knee. The vials used in the administration procedure (genvisc850, omnipaque and lidocaine) are not available, therefore an accurate assessment of the causal role of each co-suspect md/drug will be not possible. (b)(6) 2022 the hcp mentioned that they have had no other complaints (no other adverse events with genvisc 850 which includes the more than 100 injections given with the same lot number this patient received on (b)(6) 2022). This patient had 5 injections of genvisc 850 without complaints. Serratia is a very unusual bacteria to find in a healthcare setting. This patient who has diabetes is more at risk for infection in daily life. It is unlikely the genvisc 850 product or the administration procedure contributed to the bacterial infection. The investigation from genvisc lot r-12 (production lot # 28/21) bacterial & fungal testing: all results are ok and lot 28/21 passes the test as sterile.
 
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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
Manufacturer (Section G)
MEIJI PHARMA SPAIN,S.A.
avda. de madrid, 94
28802 alcalá de henares
madrid,
SP
Manufacturer Contact
dolores benedicto
avda. de madrid, 94
28802 alcalá de henares
madrid, 
SP  
MDR Report Key14323108
MDR Text Key294666412
Report Number3003184440-2022-00001
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier00850653006016
UDI-Public(01)00850653006016(17)240930(10)R12
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
PMA #140005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50653-0006-01
Device Lot NumberR-12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/07/2022 Patient Sequence Number: 1
Treatment
LIDOCAINE (LIDOCAINE); OMNIPAQUE (IOHEXOL)
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