MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ESTEEM PCH DRNWFINVISICLR60/70MM; POUCH, COLOSTOMY

Model Number 416718

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

Patient Problems Rash (2033); Tissue Damage (2104)

Event Date 02/11/2014

Event Type  Injury  

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

End user reports a red rash under the mass 360 degrees around the stoma.There was a slight amount of blood from the peristomal skin and not the stoma.She noticed it this morning.They are washing with water and applying stomahesive paste.She is also smoothing out the cut edge of the mass.Instructed the end user in skin care.Also how to apply stomahesive powder and no sting protective barrier wipes.Samples of stomahesive powder; (b)(4) cohesive slims and sensi-care no skin products will be sent.She was also instructed to call back with any questions or concerns.

• Brand Name: ESTEEM PCH DRNWFINVISICLR60/70MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5150535
• MDR Text Key: 28293112
• Report Number: 9618003-2015-30436
• 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: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2018
• Device Model Number: 416718
• Device Lot Number: 3K00587
• 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
• Date Device Manufactured: 10/13/2013
• 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: 75