MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM 1PC - 1PC DRAINABLE INVISICLOSE DRAINABLE PCH

Model Number 411203

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

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

Event Date 02/22/2012

Event Type  Injury  

Event Description

The patient reported developed a red, raised rash under the mass of the device after three days of wear.The patient reportedly cleanses the area with water.The patient discontinued use of the pouch.The skin issues resolved on their own.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.Device(s) 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.The batch record review for lot 1c03173 was performed.No discrepancies were noted in these batch records related to the complaint reported.The retained product was evaluated and the evaluation results are as follows: the samples were visually inspected and all samples appeared to be in normal condition.Leak testing was performed and passes the established specification.A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this lot was received.There is no indication of complaint trend based on this review.No nonconformance or capas relating to the primary reason for contact for this icc were found in the nonconformance reporting system for the previous 12 months of case creation.

• Brand Name: ESTEEM 1PC - 1PC DRAINABLE INVISICLOSE DRAINABLE PCH
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; hainas,san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4053566
• MDR Text Key: 4908380
• Report Number: 9618003-2014-10501
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 411203
• Device Lot Number: 1C03173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2012
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86