MAUDE Adverse Event Report: CONVATEC INC SUR-FIT NATURA 2 PC - DISPOSABLE CONVEX INSERT; APPLIANCE, COLOSTOMY, DISPOSABLE

Model Number 404009

Device Problem Increased Sensitivity (2535)

Patient Problems Unspecified Infection (1930); Viral Infection (2248)

Event Date 02/07/2014

Event Type  Injury  

Event Description

It is reported that the end-user was hospitalized on (b)(6) 2014 for a duration of three (3) weeks and receiving intravenous antibiotics via pic line for a stomach infection related to repeated use of the same convex insert.The pt was instructed, by the infectious disease doctor, to use a new convex insert each time that the wafer is changed.The end-user was using "sur-fit natura disposable convex inserts" with "sur-fit natura durahesive skin barrier w/flange".The "sur-fit natura durahesive skin barrier w/flange" was changed every three (3) days, and end-user was reusing each convex insert for eighteen (18) days.The area was washed with soap and water prior to inserting a new wafer.It is also reported that end-user used a non-convatec brand adhesive remover then applied turbo cement, and also used eakin cohesive seals before applying wafer.The product was in use for eighteen days (18) before the issue occurred.Lastly, it is reported that end-user has been discharged to home now and is afebrile and states that he is doing good and "i feel better than i have ever felt".

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.An alternate product sample has been sent, and the use of ostomy appliance belt was discussed with end-user.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 follow up report will be submitted.(b)(4) convatex will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: SUR-FIT NATURA 2 PC - DISPOSABLE CONVEX INSERT
• Type of Device: APPLIANCE, COLOSTOMY, DISPOSABLE
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3888033
• MDR Text Key: 4674374
• Report Number: 1049092-2014-00168
• Device Sequence Number: 1
• Product Code: EZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404009
• Device Catalogue Number: 404009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2014
• 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): Hospitalization; Required Intervention
• Patient Weight: 77