MAUDE Adverse Event Report: COOK INC KOYLE DIAPER URETHRAL STENT; KOD CATHETER, UROLOGICAL

Catalog Number	KDSCF-060050
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that the diaper urethral stent was blocked from inside.It was further noted that the tubing under the cuff appeared to be smashed.There were no adverse effects reported due to the event and no report of an additional procedure.

• Brand Name: KOYLE DIAPER URETHRAL STENT
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8111836
• Report Number: 1820334-2018-03566
• Device Sequence Number: 264099
• Product Code: KOD
• UDI-Device Identifier: 00827002176676
• UDI-Public: (01)00827002176676(17)180324(10)5747618
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2018
• Device Catalogue Number: KDSCF-060050
• Device Lot Number: 5747618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1