MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM AND ONE PIECE DRAINABLE CUT-TO-FIT PCH; POUCH, COLOSTOMY

Model Number 416718

Device Problem Material Disintegration (1177)

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

Event Type  malfunction  

Event Description

It was reported by the end user and his wife that the adhesive mass outside of the pouching system is disintegrating.This is the section of the mass that does not have contact with the effluent.Per the end user, this is occurring after a one day wear time and occurred in 10 one piece appliances out of a box of 10.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.Per the info received, the end user's wife discarded the box, therefore, no lot number was able to be provided.No add'l info has been provided to date.Should add'l info become available, a f/u report will be submitted.

• Brand Name: ESTEEM AND ONE PIECE DRAINABLE CUT-TO-FIT PCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a. haina; san cristobal,3 ; DR
• Manufacturer Contact: matthew walenciak, assoc. dir. ; 211 american dr; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4272077
• MDR Text Key: 5225331
• Report Number: 9618003-2014-00095
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2014
• 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
• Patient Age: 57 YR