MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA 2PC DURAHESIVE CONVEX MODABLE; PROTECTOR, OSTOMY

Model Number 404593

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ulceration (2116); Discharge (2225)

Event Date 12/05/2013

Event Type  Injury  

Event Description

Wound ostomy continence nurse reported that an ulcerated area developed at the 3 o'clock site at the edge of the stoma about three weeks ago.The area is approx 3 cm by 2.5 cm.It drains slightly and is sometimes painful.The nurse stated that the area is either from pressure or the customer has pyoderma gangrenosum.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The pt has been seen by the wound clinic at the hospital and the area is being treated with promogran to site non-convexity.The end user was referred to the wound ostomy continence nurse for ostomy eval and recommendations.The wound ostomy continence nurse reported it was too early to note changes.No add'l pt/event details have been provided to date.A return sample for eval is not expected.Should add'l info become available, a f/u report will be submitted.Note: the actual date of event is unk, so the date used was the date convatec became aware.

• Brand Name: SUR-FIT NATURA 2PC DURAHESIVE CONVEX MODABLE
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: mary szaro, associate director ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3571172
• MDR Text Key: 4048781
• Report Number: 1049092-2014-00012
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404593
• Device Catalogue Number: 404593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2013
• Initial Date FDA Received: 01/06/2014
• 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