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

Model Number 125264

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Erosion (2075)

Event Date 06/06/2013

Event Type  Injury  

Event Description

End-user reported redness and skin breakdown with weeping and itching at the left upper quadrant of peristomal skin located under wafer from approximately 6 o'clock to 8'clock position extending outside of mass and tape border.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.It is reported that end-user saw health care provider in the summer who prescribed (b)(4) powder for treatment, but declined to provide additional details.It is reported that skin care includes the use of (b)(4) body wash; (b)(4) powder intermittently.It is also reported that end-user cuts the opening in barrier larger than stoma opening.The use of non-residue soap and sealing powder in with (b)(4) skin protectant was discussed with end-user.Lastly, end-user was advised to re-size barrier and to try a wafer with moldable convexity (the (b)(4) moldable convex skin barrier with mold-to-fit opening and white tape collar (overall dimension 4.5" x 4.5"); samples of wafer were sent to end-user.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.

Manufacturer Narrative

The product associated with batch 3b02875 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.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 ; 3365424681
• MDR Report Key: 3571151
• MDR Text Key: 17837879
• Report Number: 1049092-2014-00023
• 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: 12/06/2013

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: 03/03/2018
• Device Model Number: 125264
• Device Catalogue Number: 125264
• Device Lot Number: 3B02875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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: 91