MAUDE Adverse Event Report: CONVATEC INC. NATURA WFR S/HESIVE 57MM; PROTECTOR, OSTOMY

Model Number 401576

Device Problem Leak/Splash (1354)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 08/19/2014

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation 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

Patient reports ring of reddened skin directly around stoma; is painful and bleeds at times.States irrigates daily and feels water leaks around stoma and causes irritation.Skincare reviewed.Uses bath soap; has recently tried a barrier wipe without success.Reviewed crusting techniques with stomahesive powder and wipes; has a competitors powder.Discussed moldable for better fit; sending samples to try.Will call back if does not resolve.Product use and skin care instructions provided.

• Brand Name: NATURA WFR S/HESIVE 57MM
• 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: 5154380
• MDR Text Key: 28436446
• Report Number: 1049092-2015-30599
• 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: 03/16/2019
• Device Model Number: 401576
• Device Lot Number: 4C00684
• 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: 03/17/2014
• 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: 59