MAUDE Adverse Event Report: CONVATEC, INC. ACTIVE LIFE PCH URO SM 19MM; BAG, URINARY, ILEOSTOMY

Model Number 175792

Device Problem Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 09/12/2012

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complaint reports "when she was removing her appliance, she sustained 2 small skin tears in the peristomal area at 5 to 7 o'clock.Each tear is about 1 cm x 1 cm and shallow with moist pink wound bed.She usually changes appliance every 7 days, but removed it this time on 2nd day when she noticed a small leak under mass." seen by her wound/ostomy care nurse yesterday who advised on the use of a no sting wipe.Patient called today for instruction on how to remove the pouch applied yesterday.She wanted to apply what the wound/ostome care nurse had given her.Advised not to remove it.If not leaking, leave on for usual weartime of 7 days if possible.Explained wipe was meant for use at next usual change and explained shedding of skin cells.Recommended use of adhesive remover and protective barrier wipe at each change.

• Brand Name: ACTIVE LIFE PCH URO SM 19MM
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5290133
• MDR Text Key: 33305321
• Report Number: 1049092-2015-40082
• Device Sequence Number: 1
• Product Code: EXH
• 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
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2017
• Device Model Number: 175792
• Device Lot Number: 2C01465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2012
• 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
• Treatment: PRAVACHOL
• Patient Weight: 57