MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC NATURA INVISI STD TAN BSF 45MM; POUCH, COLOSTOMY

Model Number 413334

Device Problem Defective Device (2588)

Patient Problem Skin Inflammation (2443)

Event Date 07/22/2013

Event Type  malfunction  

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 developing redness and irritation where the tail closure rubs on her skin.She uses clorox bleach to cleanse the tail closure.She recently started using a closed end pouch and since using it the redness and irritation has almost completely resolved.Product use and skin care instructions provided.

• Brand Name: NATURA INVISI STD TAN BSF 45MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC; inc.: carr. sanchez, km. 18.5; parque industrial, haina; san cristobal, 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5153713
• MDR Text Key: 28445071
• Report Number: 9618003-2015-30562
• 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
• 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
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 413334
• 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
• 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 Weight: 59