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

Model Number 401575

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

Patient Problems Abscess (1690); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Date 01/17/2013

Event Type  Injury  

Event Description

The user's brother-in-law reported the following complaint on his behalf: end user reports two peristomal abscesses; one measuring approximately the size of a quarter with tunneling and one measuring about the size of a dime.Wounds drain a small amount.Could not obtain the depth of the tunneling and the dime size wound is superficial.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user reported he changes his wafer every four-seven days and that he had been being seeing his home health at which time they were applying (b)(4) adapt powder followed by (b)(4) no sting protective barrier.End user is now being followed by his surgeon who recommended he apply (b)(4) paste to the two abscesses until there was an even pouching surface.End user reported that his surgeon biopsied the abscesses yesterday.End user was recommended the sure-fit (b)(4) moldable skin barrier and to apply (b)(4) to the abscesses covered with duoderm extra thin with each skin barrier change.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional info become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received on september 24, 2015.The product associated with lot# 2f00625 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.No further actions are required and the complaint will be closed.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

Additional information was received on october 26, 2015.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 2f00625 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 2PC STOMAHESIVE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 3596346
• MDR Text Key: 4091173
• Report Number: 1049092-2014-00034
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851840
• 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,Followup
• Report Date: 12/17/2013

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: 06/20/2013
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 2F00625
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/22/2015; 11/15/2015; 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: 82