MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 401513

Device Problem Malposition of Device (2616)

Patient Problems Tissue Damage (2104); Ulceration (2116); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.Additional information was requested.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).Note: two cases associated with this complaint.A separate 3500a form has been completed to for the other case.

Event Description

It was reported that the end user developed sores on his leg where the pouch clip rubbed.A home health nurse applied a prescription new skin to the area to prevent further breakdown.

• Brand Name: SUR-FIT NATURA DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5496702
• MDR Text Key: 40233831
• Report Number: 9618003-2016-00012
• Device Sequence Number: 1
• Product Code: EZQ
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 401513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR