MAUDE Adverse Event Report: CONVATEC INC. NATURA 2 PC STOMAHESIVE WAFER W/FLEX COLLAR ; PROTECTOR, OSTOMY

Model Number 125265

Device Problem Leak/Splash (1354)

Patient Problems Wound Dehiscence (1154); Tissue Breakdown (2681)

Event Date 12/10/2012

Event Type  Injury  

Event Description

End-user reported that the right, middle and left area of abdominal skin presented as an open wound with leakage and peeling skin, located under all of wafer; tape collar extending beyond the appliance.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.It is reported that the following skin care is performed by end-user: uses alcohol; dove soap; and stomahesive powder.End-user was provided instructions in appropriate and proper skin care.It is reported that end -user will try sur-fit natura moldable convex product with eakin cohesive seals.End-user was encouraged to follow-up with a health care provider if condition persists.Lastly, it is reported that end-user has scheduled a visit to see dermatologist.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 report will be submitted.

Manufacturer Narrative

Additional information was received on september 23, 2015.The product associated with lot#3d00375 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 complaint will remain open until 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 3d00375 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: NATURA 2 PC STOMAHESIVE WAFER W/FLEX COLLAR
• 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: 3580483
• MDR Text Key: 4060633
• Report Number: 1049092-2014-00026
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830945
• 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: 12/10/2013

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: 04/11/2018
• Device Model Number: 125265
• Device Catalogue Number: 125265
• Device Lot Number: 3D00375
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: 100