MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT NATURA UROSTOMY POUCH BEND, TRANS. ST; BAG, URINARY, ILEOSTOMY

Model Number 401553

Device Problems Product Quality Problem (1506); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Skin Erosion (2075); Blood Loss (2597)

Event Date 02/12/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Additional patient / event details have been requested.Should additional information become available a follow-up report will be submitted.Height : 72 inches.

Event Description

An end user reported a misalignment of the white plastic pouch ring to the prepared hole of the plastic pouch and when bounded by heat it leaves a serrated edge on the pouch material that is exposed to the stoma and skin "acting as a knife" which, cuts his skin and sometimes the stoma.He experienced pain and sometimes bleeding with movement.The end user further informed that he has seen a stoma therapist.

Manufacturer Narrative

Additional information was received on august 31, 2015.Confirmation was received that the incorrect icc code was recorded on the initial mdr that was reported to the fda on march 20, 2015 - mfr# 9618003-2015-00009.Section has been updated to reflect the applicable information.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: SUR-FIT NATURA UROSTOMY POUCH BEND, TRANS. ST
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; haina, san cristobal 3 ; DR
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4645052
• MDR Text Key: 121612034
• Report Number: 9618003-2015-00009
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/15/2019
• Device Model Number: 401553
• Device Lot Number: 4L03011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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 Weight: 84