MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA® DRAINABLE POUCH 12" OPAQUE; POUCH, COLOSTOMY

Model Number 404017

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Additional information has been requested.Should additional information become available a follow-up report will be submitted (b)(4).Note: this complaint issue occurred on (3) separate cases.A separate 3500a form has been completed for the other (2) cases.

Event Description

End user reports redness under wafer without itching.End user states she has tried a different wafer with same issue occurring.Dermatologist prescribed unknown ointment that she has not used.End user also states she has an itchy red area in groin under the pouch that she states is a reaction to both the pouch and wafers.

• Brand Name: SUR-FIT NATURA® DRAINABLE POUCH 12" OPAQUE
• Type of Device: POUCH, COLOSTOMY
• 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: 5205650
• MDR Text Key: 30568251
• Report Number: 1049092-2015-00647
• Device Sequence Number: 1
• Product Code: EZQ
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR