MAUDE Adverse Event Report: CONVATEC INC. ACTIVE LIFE PCH SM CLR 22MM; POUCH, COLOSTOMY

Model Number 175778

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/01/2014

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 a small amount of blood; approximately a couple of teaspoons; appeared in her pouch.She was evaluated by her healthcare provider who recommended hydrogen peroxide to the stoma and the bleeding stopped.She said her healthcare provider did not note any cut or bruise to the stoma whatsoever.Her stoma was measured at 25 mm and it has been recommended that she use an appliance with a 25 mm opening.Customer has experienced no further episodes of bleeding since adjusting to the larger mass opening.Cwon from (b)(6) advised that her stoma measures 25 mm; and she should use a mass with opening of 25 mm.Wocn offered samples of coloplast ctf.

• Brand Name: ACTIVE LIFE PCH SM CLR 22MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5153622
• MDR Text Key: 28451884
• Report Number: 1049092-2015-30550
• 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

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/03/2018
• Device Model Number: 175778
• Device Lot Number: 3K00396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• 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: 68