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

Model Number 404593

Device Problem Leak/Splash (1354)

Patient Problem Fluid Discharge (2686)

Event Date 12/12/2013

Event Type  Injury  

Event Description

The end user reported one month history of open areas under wafer next to stoma wear time is one to two days; then weeping occurs and wafer leaks.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user reported she was on oral antibiotics for one week in november.Skincare was reviewed with the end user and she stated she is crusting with powder and allkare.She used stomahesive strips to fill increases and uses skin over the top then wafer.She stated that the areas are painful also will try larger eakin and precut wafer wears belt.It was discussed that she sees her local wound ostomy continence nurse.No additional pt/'event details have been provided to date.Should additional info become available a follow-up report will be submitted.Note: the actual date of event is unk, so the date used was the date convatec became aware.

Manufacturer Narrative

No previous investigations are available.No returned samples were expected and none have been received.A detailed batch review of the associated lot revealed no discrepancies (includes non-conformances/deviations).There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.Device manufacture date corrected.No additional patient/event details have been provided to date.Should additional information become available, a follow-up 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 3581053
• MDR Text Key: 4142560
• Report Number: 1049092-2014-00030
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/12/2013

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 Expiration Date: 10/27/2018
• Device Model Number: 404593
• Device Catalogue Number: 404593
• Device Lot Number: 1156501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2013
• 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