MAUDE Adverse Event Report: CONVATEC INC. NATURA WFR MLD CVX 22/45MM; PROTECTOR, OSTOMY

Model Number 404593

Device Problem Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 05/25/2014

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

Patient reports 3 month history of leaking wafer and open skin around stoma as well as healing cuts into stoma.States home health nurses instructed him to cut the moldable wafer which approximately 1 month ago caused a cut to the stoma; which he states is now almost healed.States skin around stoma is brown in color with open skin directly around stoma from urine leaking there.Uses dial soap.No wipes.Has been using duck tape around tape border to hold on wafer.Product use and skin care instructions provided - recommended stomahesive powder and crusting technique.

• Brand Name: NATURA WFR MLD CVX 22/45MM
• Type of Device: PROTECTOR, OSTOMY
• 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: 5153767
• MDR Text Key: 28437009
• Report Number: 1049092-2015-30566
• Device Sequence Number: 1
• Product Code: EXE
• 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 Expiration Date: 02/23/2018
• Device Model Number: 404593
• Device Lot Number: 3B01987
• 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: 02/24/2013
• 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: 95