MAUDE Adverse Event Report: CONVATEC INC. NATURA®+ UROSTOMY SMALL POUCH WITH SOFT TAP; BAG, URINARY, ILEOSTOMY

Model Number 421074

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fever (1858); Hematoma (1884); Pain (1994); Vomiting (2144); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No sample returned and no lot number is available.Therefore, a detailed investigation or batch review cannot be conducted.Additional information has been request, but was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Complaint reported by the mother of (b)(6) son who has a stoma and since pouching the stoma there was increased amounts of blood in the urine.When the physician tested the urine there was a staph infection that reportedly affected the end user's kidneys as well.The end user was hospitalized, treated with unknown prescription antibiotics and is now home and has recovered from the event.It was reported that the mother did not hook pouch up to drainage system at night and pouch would become at least half full.No further details are available.

Manufacturer Narrative

This supplemental is being submitted as it was later reported by the complainant that the child is doing fine after the reported event.It was stated that in the past the patient had urinary track infections (uti) but the growth of the staph infection may have started after using the pouch system.The patient had severe pain, fevers and wouldn't move.It was noted that the last serious infection occurred on (b)(6) 2016.The night before the patient complained of stomach pain and woke up with a huge blood clot coming from the stoma site and was then rushed by ambulance to the hospital.The patient was also vomiting what looked like blood and was treated again for a staph infection.It was suggested by their ostomy nurse to remove the pouch before bed time and put the patient back on diapers because they were not using a draining pouch for overnight.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: NATURA®+ UROSTOMY SMALL POUCH WITH SOFT TAP
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6181954
• MDR Text Key: 62611056
• Report Number: 1049092-2016-00488
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 421074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ANTIBIOTICS (BRAND NOT SPECIFIED)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 19