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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE SELECT GUIDING SHEATH DYB INTRODUCER, CATHETER

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COOK INC FLEXOR SHUTTLE SELECT GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KSAW-6.0-38-90-RB-SHTL-FLEX-HC
Device Problem Contamination /Decontamination Problem (2895)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameFLEXOR SHUTTLE SELECT GUIDING SHEATH
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 Key15293585
Report Number1820334-2022-01402
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153430
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,Followup
Report Date 10/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKSAW-6.0-38-90-RB-SHTL-FLEX-HC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received10/12/2022
Was Device Evaluated by Manufacturer? Yes
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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