MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC NATURA INVISI STD CLR BSF WF45MM; POUCH, COLOSTOMY

Model Number 411360

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problem Tissue Damage (2104)

Event Date 12/10/2013

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).Evaluation conclusions are reflected in the codes.

Event Description

Son called to report his mothers stoma was cut due to a rough spot on the filter on the inside of the pouch.Son describes the bleeding as occurring at 10 pm and stopped by midnight.Encouraged follow-up with healthcare provider.

• Brand Name: NATURA INVISI STD CLR BSF WF45MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5138781
• MDR Text Key: 27899110
• Report Number: 9618003-2015-30384
• 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: Other
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/26/2018
• Device Model Number: 411360
• Device Lot Number: 3C02659
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2013
• 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 Weight: 54