MAUDE Adverse Event Report: NATURA; POUCH, COLOSTOMY

Model Number 401557

Device Problem Off-Label Use (1494)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Based on the available information, the event is deemed to be a reportable serious injury.Additional follow-up has been requested from the complainant regarding the event in (b)(6) for the uti that the end user experienced during a hospitalization and release.At this time, no further details have been provided as the product brand is unknown and there was no conformation it was a convatec product.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional information has been requested but has not been received to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

The end user reports that she was recently hospitalized on (b)(6) 2017, with a urinary tract infection (uti).The wound, ostomy and continence (woc) nurse at the hospital told the end user the uti was due to her using a colostomy pouch for her urostomy instead of a urostomy pouch.¿it is the opinion of the end user that she developed the uti due to using the wrong style pouch.She ordered it herself not knowing that it wasn't a urostomy pouch.She now understands the difference.¿ the end user reported having nausea, vomiting, diarrhea, passed out and hit head during the night on (b)(6) 2017.On (b)(6) 2017, she went to the hospital.At that time the end user was diagnosed with another uti.The product was removed by the woc nurse at the hospital, who felt the reason for the uti was that the end user was using a colostomy pouch and it was replaced with a urostomy pouch.The end user was hospitalized for 7 days and treated for a uti with iv antibiotics (unknown brand).She is home and no further antibiotics is needed and is currently using a urostomy pouch.No further signs of infection at this time and no further details have been provided.

• Brand Name: NATURA
• Type of Device: POUCH, COLOSTOMY
• MDR Report Key: 7098019
• MDR Text Key: 94194004
• Report Number: 9618003-2017-00047
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 401557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR