MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC ACTIVE LIFE PCH STD CLR CUST; POUCH, COLOSTOMY

Model Number 22771

Device Problem Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 06/20/2014

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

Reports blistering and bleeding to peristomal skin on left upper quadrant of abdomen.States leaking has been occuring due to stomal retraction under pouches since 2 weeks after surgery and at times goes through 2 to 3 pouches per day.Stoma is retracted.States there is blistering around opening out to approximately 40mm outward on peristomal skin and there are parts of skin that are bleeding.Has been using crusting technique with stomahesive powder and (b)(6) protective wipes.Product use and skin care instructions provided.

• Brand Name: ACTIVE LIFE PCH STD CLR CUST
• 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: 5153632
• MDR Text Key: 28411547
• Report Number: 9618003-2015-30551
• 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: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22771
• 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
• 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: 122