MAUDE Adverse Event Report: CONVATEC INC. DOMINICAN REPUBLIC, INC. SUR-FIT NATURA 2PC UROSTOMY POUCH W/ACCUSEAL; BAG, URINARY, ILEOSTOMY

Model Number 401544

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

End user reported the anti reflux valve is not working in his urostomy pouches.He stated that the urine is mostly staying at the top of the pouch with a small amount getting to the bottom.

Manufacturer Narrative

Based on the available information this event is deemed a reportable malfunction.The device was used by the patient, however, there was no report of injury to the patient.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.A return sample for evaluation is not expected.

• Brand Name: SUR-FIT NATURA 2PC UROSTOMY POUCH W/ACCUSEAL
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC. DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, dir. of medic ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3956946
• MDR Text Key: 4623857
• Report Number: 9618003-2014-00059
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2018
• Device Model Number: 401544
• Device Catalogue Number: 401544
• Device Lot Number: 3J00215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1