MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT NATURA® UROSTOMY POUCH WITH ACCUSEAL®; BAG, URINARY, ILEOSTOMY

Model Number 401544

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Date of event: (b)(6) 2015.Reported to the fda on january 20, 2016.(b)(4).

Event Description

It was reported the end user forgot to open the tap of the urostomy pouch before connecting the pouch to the nighttime drainage device.As a result, the pouch overfilled and did not drain into the nighttime drainage device.The next morning, the end user complained of bilateral flank pain and he was concerned the overfilled pouch allowed urine to backflow into his "urinary system." he presented to the emergency room.A urine specimen was taken; however, the results were inconclusive.The end user was issued a prescription for a course of antibiotics (amoxicillin).The end user further reported that although he did not finish taking the antibiotics, the pain resolved with no recurrence.No additional complications were reported as a result of this event.

• Brand Name: SUR-FIT NATURA® UROSTOMY POUCH WITH ACCUSEAL®
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; lot 30 - piisa industrial park; carretera sanchez km. 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365244681
• MDR Report Key: 5381289
• MDR Text Key: 36449749
• Report Number: 9618003-2016-00002
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 401544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 72 YR