MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the black silicone ureteral stent had migrated into the kidney.No other information has been provided by the reporter as of the date of this report.

Manufacturer Narrative

Investigation ¿ evaluation: the stent was not returned for analysis and no photographs were provided.A physical investigation could not be performed.Without the part number, lot number or the returned device the complaint cannot be confirmed and a specific root cause cannot be determined.The lot number was not provided therefore a review of the device history record was unable to be performed.If the device and lot number information are received a review of complaint history for related complaints will be reviewed.Per the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNKNOWN
• 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: 5842713
• MDR Text Key: 51006636
• Report Number: 1820334-2016-00715
• 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: 09/01/2017

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?: 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
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/01/2017
• 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
• Patient Outcome(s): Other