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

Model Number 404592

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 12/05/2013

Event Type  Injury  

Event Description

End user's daughter reported for one week end users' peristomal skin from 4 o'clock to 7 o'clock area has been red and blistered.The end user's daughter reported that the end user has not been applying anything to area.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user's daughter was advised to apply (b)(4) powder to blistered skin and then use (b)(4) barrier spray to crust area.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Note: the actual date of event is unknown, so the date used was the date convatec became aware.

• Brand Name: SUR-FIT NATURA 2PC DURAHESIVE CONVEX MOLDABLE
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: mary szaro, director ; 200 headquarters park dr.; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3571148
• MDR Text Key: 22138565
• Report Number: 1049092-2014-00007
• 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: 12/05/2013

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: 404592
• Device Catalogue Number: 404592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2013
• 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: 57