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

Model Number 404593

Device Problem Insufficient Information (3190)

Patient Problem Erythema (1840)

Event Date 12/06/2013

Event Type  Injury  

Event Description

End user reported he has a straight line of redness from four to seven o'clock and from eleven to one o'clock.Does not have any itching or burning and there is not a raised rash, only redness.Did say have always been using powder everywhere under wafer with barrier wipe.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.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.(b)(4).

• 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: 3571177
• MDR Text Key: 20701696
• Report Number: 1049092-2014-00018
• 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: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• 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?: No
• Date Manufacturer Received: 12/06/2013
• 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 Weight: 91