MAUDE Adverse Event Report: CONVATEC, INC. NATURA WFR CVX 19/45MM; PROTECTOR, OSTOMY

Model Number 413179

Device Problem Leak/Splash (1354)

Patient Problems Skin Erosion (2075); Skin Irritation (2076)

Event Date 02/22/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Customer reports he has had a gastrointestinal bug that has caused diarrhea for several days during which time he also had leakage of stool onto his skin from under the wafer.He reports several ulcerated areas under the mass; the tape border and under the tape that he uses to create a picture frame around the edges.The ulcers are shallow; pink and moist different sizes and shapes but about size of a dime and are painful.He has not seen his healthcare provider.He has applied stomahesive powder and is using a spray protective barrier.He reports that he had this happen in the past and used a dressing that sounds like a duoderm xtra thin but he was not sure of the name.He is feeling better and denies dehydration.He will call hcp if there is no improvement in his skin.

• Brand Name: NATURA WFR CVX 19/45MM
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5153068
• MDR Text Key: 28381917
• Report Number: 1049092-2015-30453
• Device Sequence Number: 1
• Product Code: EXE
• 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
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2018
• Device Model Number: 413179
• Device Lot Number: 3H00109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2013
• 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 Weight: 100