MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016, a male patient of unknown age reported to (b)(4) his intestinal tube had been pulled out partially on (b)(6) 2016.The patient pushed the tube back in and tried to keep using duopa.The patient found that the duopa wasn't' working at all for him.The patient stopped using duopa on (b)(6) 2016.The tube was replaced with the same product.

Manufacturer Narrative

Investigation - evaluation: a review of complaint history, manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the limited information provided and results of the investigation a definitive root cause could not conclusively be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• 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: 5999720
• MDR Text Key: 57083727
• Report Number: 1820334-2016-01107
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/26/2017
• 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