MAUDE Adverse Event Report: CONVATEC INC. ESTEEM 1 PC - DRAINABLE INVISICLOSE DRAIN PCH; POUCH, COLOSTOMY, 78EZQ

Model Number 416740

Device Problem Increased Sensitivity (2535)

Patient Problem Skin Irritation (2076)

Event Date 05/26/2014

Event Type  Injury  

Event Description

It is reported that end-user has developed re, blotchy areas located under the tape border for one (1) month resulting in frequent (every 2 days) pouch changes.It is further reported that there is stool leakage under the tape border located at the 9 o'clock position which causes skin irritation.Lastly, it is reported that treatment for this issue has been administered with desitin and prescription triamcinolone cream.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.It is reported that the product was in use for two (2) to three (3) days before issue occurred.Further skin care routine is as follows: uses dial soap; sensicare wipes; airs out skin and applies desitin daily and also tried triamcinolone cream.End-user was provided instructions in crusting techniques with stomahesive powder and allkare wipes, to stop using desitin for now and try belt, and to fill crease with eakin cohesive seals.Lastly, end-user was advised to notify convatec with any questions, concerns and if condition persists.No add'l pt/event details have been provided to date.A return sample for eval is not expected.Should add'l info become available, a follow up report will be submitted.(b)(4).Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

• Brand Name: ESTEEM 1 PC - DRAINABLE INVISICLOSE DRAIN PCH
• Type of Device: POUCH, COLOSTOMY, 78EZQ
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3876023
• MDR Text Key: 4594529
• Report Number: 1049092-2014-00238
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416740
• Device Catalogue Number: 416740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 63