• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING / BIO - TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 10MG/ML SYRINGE ACID, HYALURONIC, INTRAARTICULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FERRING / BIO - TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 10MG/ML SYRINGE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number P14216A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 09/23/2019
Event Type  Injury  
Event Description
The pt was hospitalized, dates unk. Reason: combat infection (knee replacement occurred (b)(6) 2019). The pt reported was hospitalized for bacterial infection from old bladder surgery, has been experiencing reactions (possibly allergic) to many antibiotics, unable to subdue this bacteria, is consulted an infectious disease specialist then an allergist to determine if reactions are truly allergic reactions. Mdo-info: (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEUFLEXXA 10MG/ML SYRINGE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING / BIO - TECHNOLOGY GENERAL (ISRAEL) LTD.
MDR Report Key9279492
MDR Text Key165273047
Report NumberMW5090867
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2020
Device Lot NumberP14216A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 11/04/2019 Patient Sequence Number: 1
-
-