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

Model Number 411802

Device Problem Insufficient Information (3190)

Patient Problem Itching Sensation (1943)

Event Date 12/05/2013

Event Type  Injury  

Event Description

The end user reported over the past four months she has noticed itchiness under tape collar sometimes.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user reported that she cleans with (b)(4) soap.She uses competitive brand adhesive remover and her wear time three or four days.She has used product for four months.The end user also reported that the issue resolves when she self medicates with steroid cream.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.(b)(4).Note: the actual date of event is unknown, so the date used was the date convatec became aware.

• Brand Name: SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER
• 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: 3571158
• MDR Text Key: 4215771
• Report Number: 1049092-2014-00010
• 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: 411802
• Device Catalogue Number: 411802
• 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 Outcome(s): Required Intervention