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

Model Number 411804

Device Problem Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Date 11/18/2013

Event Type  Injury  

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.End-user reported no change in skin care, and that she is currently using an (b)(4) seal and (b)(4) powder.End-user was instructed in skin care and crusting techniques by using (b)(4) powder and no-sting protective barrier wipes.End-user reported that she is currently wearing a flat wafer; therefore, a convex moldable wafer will be sent.A sample of the sensi-care sting free skin barrier wipes and the adhesive barrier were sent to end-user.Lastly, end-user was instructed to notify convatec with any questions or concerns.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.Reported to the fda on (b)(6) 2014.

Event Description

End-user reported red excoriated areas at the right lower quadrant/6 o'clock position under wafer's mass but not extending beyond the mass.End-user describes these areas between 25mm and 38mm in size and extends away from the stoma approximately 13mm.It is reported that this issue began on (b)(6) 2013.

Manufacturer Narrative

Additional information was received on september 23, 2015.The product associated with lot#3f00045 was manufactured according to specification.After a thorough batch review no discrepancies or non-conformances were discovered.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.Previous investigation is applicable to this complaint.Therefore this complain will remain open until the completion of the investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

The product associated with batch 3f00045 was made according to specification.After detailed batch review, no discrepancies, including non-conformances/deviations, were found.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous non-conformance is applicable to this complaint and is closed.No further actions are required, and this complaint will be closed.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.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 2 PC DURAHESIVE MOLDABLE WAFER
• 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 ; 3362973009
• MDR Report Key: 3571149
• MDR Text Key: 21273697
• Report Number: 1049092-2014-00020
• 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: 12/06/2013

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 Expiration Date: 06/14/2018
• Device Model Number: 411804
• Device Catalogue Number: 411804
• Device Lot Number: 3F00045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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 Weight: 90