MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC ACTIVE LIFE PCH CLD CLR 19MM; POUCH, COLOSTOMY

Model Number 175761

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 05/12/2014

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

Customer reports that when she attempted to remove her pouch on (b)(6) 2014, she found the adhesive was very aggressive especially the bottom half.She uses no accessories.She tried using aloe vesta cleansing foam to help to loosen the appliance but it did not help.She states she irritated the skin at the base of the stoma and had some bleeding at the junction of the skin and stoma all the way around in a thin line.She reapplied a pouch from the same box.Product use and skin care instructions provided.

• Brand Name: ACTIVE LIFE PCH CLD CLR 19MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC INC; carr. sanchez, km. 18.5; parque industrial, haina; san cristobal, 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5155605
• MDR Text Key: 28449368
• Report Number: 9618003-2015-30620
• 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: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/17/2018
• Device Model Number: 175761
• Device Lot Number: 3J00155
• 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: 09/18/2013
• 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 Weight: 59