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Model Number N/A
Device Problem Device Disinfection Or Sterilization Issue (2909)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use, and quality control of the returned device were conducted during the investigation. As of (b)(6) 2017, the device was not returned to the manufacturer for evaluation and marked in the complaint record that will not be returned and no photos were provided. If the device is returned the record will be updated at that time. A review of the nonconformance data revealed two non-conformances that affected 2 products in this lot. This nonconformance is not related to this complaint. A review of the complaint history revealed a total of two complaints are related to this complaint but have different failure modes. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Manufacturer Narrative
The event is currently under investigation. A follow up report will be send upon conclusion.
Event Description
It was reported by the user facility that a patient was using a cook drainage pouch set and had recurring bladder infections. The physician stated that the drainage pouch is causing the infections. There was no information provided as to the treatment of the recurring bladder infections. An attempt was made to determine if the patient was using the cook drainage pouch set for more than one day and whether or not the patient was cleaning the pouch and rotating between two of them as directed in the instructions for use (ifu). The reporter was also asked if there was any kinks in the drainage tubing attached to the pouch. At this time no further information has been provided by the reporter. The ifu states: with proper care, the appliance may be worn 10-14 days. Wearing times may vary depending on body metabolism. It is recommended that two appliances be used interchangeably so a fresh appliance can be applied daily. The connecting tube may be cut to fit the patient. Disconnect the tube at the pouch, remove excess tubing from the distal end, and replace. Caution: care must be exercised when determining appropriate connecting tube length; improper length may cause the tube to kink, resulting in urine reflux to the kidney(s). Periodic examination of the connecting tube is recommended.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key6446130
MDR Text Key113302149
Report Number1820334-2017-00518
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number505003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/30/2017 Patient Sequence Number: 1