MAUDE Adverse Event Report: CONVATEC LIMITED NATURA PCH DRN STD TAN 45MM; POUCH, COLOSTOMY

Model Number 411491

Device Problem Defective Device (2588)

Patient Problem Skin Inflammation (2443)

Event Date 08/08/2014

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

It was reported a rash between legs.End user attributes to clip from pouch tail.

• Brand Name: NATURA PCH DRN STD TAN 45MM
• 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: 5154048
• MDR Text Key: 28445322
• Report Number: 1000317571-2015-30581
• 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: 411491
• 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