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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEIJI PHARM SPAIN TRIVISC; ACID, HYALURONIC, INTRAARTICULAR

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MEIJI PHARM SPAIN TRIVISC; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problems Failure to Deliver (2338); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/07/2022
Event Type  malfunction  
Event Description
Trivisc syringes are breaking during administration where hub and syringe attach.Needle is left in the patient and the syringe with drug is broken off resulting in incomplete administration of medication and patient requiring to be stuck again with a new syringe; 5 syringes over last 7 days.
 
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Brand Name
TRIVISC
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
MEIJI PHARM SPAIN
MDR Report Key14986873
MDR Text Key295796008
Report NumberMW5110799
Device Sequence Number5
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 07/08/2022
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/11/2022
Patient Sequence Number1
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