MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ACTIVE LIFE PCH CLD CLR 38MM; POUCH, COLOSTOMY

Model Number 175764

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

Patient Problem Tissue Damage (2104)

Event Date 02/06/2014

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 calls to report bleeding from stoma where the stoma meets her skin.Complainant has confirmed that product lot number is not available and will not be retrievable.Describes eating kale and spinach has been eating high potassium foods.Advised to remove pouch and inspect stoma for trauma.No trauma noted.Advised to remove pouch and hold pressure on site of bleeding.She reports it has stopped bleeding.Advised to call physician.Reviewed anticoagulation properties of aspirin and foods.Instructed in appropriate skin care routine.

• Brand Name: ACTIVE LIFE PCH CLD CLR 38MM
• 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: 5150525
• MDR Text Key: 28293421
• Report Number: 9618003-2015-30432
• 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: Other
• 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 Model Number: 175764
• Was Device Available for Evaluation?: 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 Outcome(s): Required Intervention
• Patient Weight: 68