MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM 1PC-1PC DRAINABLE INVISICLOSE POUCH APS; PROTECTOR, OSTOMY

Model Number 416719

Device Problem Human-Device Interface Problem (2949)

Patient Problems Irritation (1941); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received that adhesive is too aggressive and when the pouch is removed it leave reddened skin.The patients subsequent outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Devices listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.It is noted that there are blank areas on this form, the information was not provided or is unknown.

• Brand Name: ESTEEM 1PC-1PC DRAINABLE INVISICLOSE POUCH APS
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greesboro, NC 27409 ; 9083779293
• MDR Report Key: 4023929
• MDR Text Key: 15328834
• Report Number: 9618003-2014-10809
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: E584639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/17/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2012
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention