MAUDE Adverse Event Report: COOK INC UNKNOWN; FAD STENT, URETERAL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

The physician stated his patients complain about pain and discomfort with the cook stents.

Manufacturer Narrative

Investigation ¿ evaluation.The ureteral stent was not returned therefore a physical investigation could not be performed.The complaint was unable to be confirmed and the root cause of the reported patient¿s complaint of pain and discomfort with the cook stents was not able to be determined.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The model and lot number of the implicated device were not provided; therefore, a review of the device history record for non-conformances cannot be completed.Additionally, a review of complaint history for other associated complaints could not be completed.Should additional information be received, this complaint will be updated accordingly.Based on the information provided, the actual root cause is unknown.Based on the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor the complaints database for similar complaints.

• Brand Name: UNKNOWN
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6205003
• MDR Text Key: 63305740
• Report Number: 1820334-2016-01629
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1