MAUDE Adverse Event Report: CONVATEC LIMITED ESTEEM 1-PIECE DRAINABLE POUCH W/INVISICLOSE TAIL CLOSURE AND FILTER - TRANSPARE; POUCH, COLOSTOMY

Model Number 411204

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

Patient Problems Rash (2033); Skin Irritation (2076)

Event Date 02/02/2012

Event Type  Injury  

Event Description

The customer reported she developed skin redness and a rash under the device mass during a period of 3 weeks prior to complaint receipt.Per wocn, the device was discontinued and replaced with a device of a different brand.The pt noted relief within 12 hours.No further pt complications were reported.

Manufacturer Narrative

A batch record review for this lot was performed.No discrepancies or nonconformances were noted in these batch records related to the complaint reported.The retained sample product was evaluated.A visual inspection found all samples to be in normal condition.Leak testing was performed and no anomalies were noted.A review of complaints for previous 12 months was performed and there are no nonconformances or indication of complaint trend.Convatec is submitting this report as a result of remediation activities related to the fda 483 issued on 04/16/2014.Device (s) listed in this report is (are) used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.Brand name: esteem 1-piece drainable pouch w/invisiclose tail closure and filter - transparent w/cut-to-fit opening.

• Brand Name: ESTEEM 1-PIECE DRAINABLE POUCH W/INVISICLOSE TAIL CLOSURE AND FILTER - TRANSPARE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; unit 20, first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, dir, qlty engr ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147587
• MDR Text Key: 4912941
• Report Number: 1000317571-2014-10497
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2015
• Device Model Number: 411204
• Device Lot Number: 0M00693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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