MAUDE Adverse Event Report: CONVATEC INC. NATURA® MOLDABLE DURAHESIVE® SKIN BARRIER; PROTECTOR, OSTOMY

Model Number 411802

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Previous applicable non conformance investigation has been completed.The investigation revealed that the complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user as 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 further information is available at this time.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

End user reports 12 weeks ago, he developed a peristomal ulcer at the 8 to 9 o'clock position that migrated to the 7 o'clock position.The area was approximately 18 mm round with shallow depth and about 1/8th inch away from the stoma.End user saw a physician at a wound care clinic and they treated the area with stomahesive powder, endoform, aquacel extra and duoderm at various points.The doctor eventually treated the area with silver nitrate and it resolved after about 4 to 5 weeks.End user reports bleeding occurs and is treated with silver nitrate.He is not able to quantify the bleeding.End user further states there is no pain or discoloration around the ulcer, however the ulcer does lie partly underneath the flange.End user received samples of natura moldable durahesive skin wafers that are helping.End user states with last pouch change the area was almost completely resolved.

• Brand Name: NATURA® MOLDABLE DURAHESIVE® SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5399494
• MDR Text Key: 37178440
• Report Number: 1049092-2016-00021
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 411802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 79 YR