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

Model Number 413418

Device Problem Leak/Splash (1354)

Patient Problems Pain (1994); Skin Irritation (2076); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.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 october 13, 2015.(b)(4).

Event Description

End user reports intermittent peristomal skin redness under the mass and white tape collar.She said this occurs when she notes stool on her skin.She said she is not always able to change her wafer right away when it needs it so she feels this contributes to her intermittent red skin.Her doctor prescribed nystatin powder to be applied to this intermittent red skin.Currently she has a smooth red and shiny area next to her stoma at 1100-1200 o'clock which measures approximately 22mm.She does experience pain and a small amount of bleeding from this area at times.Bleeding occurs when she changes her wafer and it resolves without intervention.

• Brand Name: NATURA® MOLDABLE DURAHESIVE® SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5147908
• MDR Text Key: 28199115
• Report Number: 1049092-2015-00596
• 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
• Report Date: 09/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2015
• 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
• Treatment: GABAPENTIN
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 59