MAUDE Adverse Event Report: CONVATEC INC. ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT P; PUCH, COLOSTOMY

Model Number 416740

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Event Description

It was reported that the "wafer was too sticky" and, as a result, was "difficult to remove." no patient complications were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed to be reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

The product associated with this complaint investigation, was made according to specification.No previous investigations are available.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.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: ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT P
• Type of Device: PUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4794873
• MDR Text Key: 15915220
• Report Number: 1049092-2015-00270
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 416740
• Device Lot Number: 4M01754
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1