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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER DYB INTRODUCER, CATHETER

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COOK INC PERFORMER INTRODUCER DYB INTRODUCER, CATHETER Back to Search Results
Model Number G27023
Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2022
Event Type  malfunction  
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Brand NamePERFORMER INTRODUCER
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key15165464
Report Number1820334-2022-01310
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002270237
UDI-Public(01)00827002270237(17)250517(10)14737446
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG27023
Device Catalogue NumberRCFW-16.0P-38-35-RB
Device Lot Number14737446
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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