MAUDE Adverse Event Report: CONVATEC INC. ESTEEM 1 PC UROSTOMY POUCH W/FOLD UP TAP; URINARY, ILESTOMY

Model Number 401232

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

An end user reported urine cannot flow into the pouch because the inner membrane is fused.

Manufacturer Narrative

Based on the available information this event is deemed a reportable malfunction.The device was used by an end user, however there was no report of harm 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: ESTEEM 1 PC UROSTOMY POUCH W/FOLD UP TAP
• Type of Device: URINARY, ILESTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3979523
• MDR Text Key: 16857981
• Report Number: 9618003-2014-00067
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 401232
• Device Catalogue Number: 401232
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2014
• 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