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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 10 MG/ML 2ML (6=3SYR) ACID, HYALURONIC, INTRAARTICULAR

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BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 10 MG/ML 2ML (6=3SYR) ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number T10187A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 09/16/2021
Event Type  Death  
Event Description
Event: pt's daughter reported pt passed away (b)(6) 2021. Inject 1 syringe intra-articularly into the left knee once a week for 3 weeks.
 
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Brand NameEUFLEXXA 10 MG/ML 2ML (6=3SYR)
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
MDR Report Key13059205
MDR Text Key282615163
Report NumberMW5106171
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberT10187A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
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