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

Model Number 411804

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Date 01/09/2013

Event Type  Injury  

Event Description

The end user reported redness with itching beneath mass at six to nine o'clock; two to three areas approx the size of a pencil eraser.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user reported using polysporin; disinfectant.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 f/u report will be submitted.Reported to fda on (b)(4) 2014.

Manufacturer Narrative

Additional information was received on october 16, 2015.The product associated with lot# 3h00558 was manufactured according to specification.After a thorough batch review, no discrepancies, non-conformances or deviations 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 investigation.Therefore, this complaint will remain open until completion of the previous 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 3h00558 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.Reported to the fda on january 21, 2016.(b)(4).

• Brand Name: SUR-FIT NATURA 2PC 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: 3571170
• MDR Text Key: 4215776
• Report Number: 1049092-2014-00013
• 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,Followup
• 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 Expiration Date: 09/09/2018
• Device Model Number: 411804
• Device Catalogue Number: 411804
• Device Lot Number: 3H00558
• 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: 09/01/2013
• 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 Outcome(s): Required Intervention
• Patient Weight: 68