MAUDE Adverse Event Report: CONVATEC LIMITED NATURA INVISI STD TAN DSF WF45MM; POUCH, COLOSTOMY

Model Number 411350

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

Patient Problem Tissue Damage (2104)

Event Date 08/18/2014

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

Enduser reported that he normally uses another company products, convatec products only when staying in warmer regions.He used the convatec pouch from (b)(6).According to end user the filter of pouch irritated stoma.After one day stoma was swollen, bled a little bit.After 4 days enduser stopped using product and on (b)(6) his stoma had normalized again.

• Brand Name: NATURA INVISI STD TAN DSF WF45MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first ave; deeside industrial park; deeside, flintshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5155543
• MDR Text Key: 28443423
• Report Number: 1000317571-2015-30604
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/07/2019
• Device Model Number: 411350
• Device Lot Number: 4A00860
• 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: 01/08/2014
• 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