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

MAUDE Adverse Event Report: COOK INCORPORATED NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL

  • 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
 

COOK INCORPORATED NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Lot Number 7465146
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 01/17/2017
Event Type  malfunction  
Event Description
Basket didn't open or close properly. It didn't function.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNGAGE
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key6990530
MDR Text Key90693725
Report Number6990530
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2019
Device Lot Number7465146
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2017
Event Location Hospital
Date Report to Manufacturer09/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-