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

Model Number 413155

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Fungal Infection (2419)

Event Date 02/02/2014

Event Type  Injury  

Event Description

End user reported she has had a rash for several years under the whole wafer.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user reports she was prescribed nystop for a yeast infection.No additional event details have been provided to date.A return sample for evaluation is not expected.Should pt/event details become available a follow-up report will be submitted.

• Brand Name: SUR-FIT NATURA 2PC DURAHESIVE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc director ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042287
• MDR Report Key: 3717091
• MDR Text Key: 4232088
• Report Number: 1049092-2014-00072
• 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: 02/24/2014

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: 413155
• Device Catalogue Number: 413155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/20/2014
• 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
• Patient Weight: 86