MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 416718

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 30-apr-2021.Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on 25-mar-2016.On 01-apr-2016, the following corrections were identified : corrected data: manufacture name, city and state updated.Manufacturer report(mfr)number was previously reported in error as 9618003-2016-00013 on the initial report, submitted to the fda on march 25, 2016.The new mfr# is 1049092-2016-00186.Device manufacture date updated.The codes were reported in error on initial mfr#: 9618003-2016-00013, reported to the fda on march 25, 2016 and have been corrected with the appropriate codes: no additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 26-apr-2016.On 17-jun-2016, the following information was received : a bulk record review was performed by two (2) manufacturing sites.There were no discrepancies related to the complaint found in either site's records.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the process instructions.The process requirements results were documented in the product batch records.No further action is required and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 11-jul-2016.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

The end user reported that the barrier "liquified and became slimy feeling" while he was in the shower.Afterwards the barrier "re-solidified and then became brittle." according to the end user, he removed it because it felt irritating.He stated that the barrier was very hard to remove from the skin and left a residue that was hard to remove even with adhesive removers.He noted at that time the skin was intact without irritation.

• Brand Name: ESTEEM ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5607979
• MDR Text Key: 266972853
• Report Number: 1049092-2016-00186
• 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: Other
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2020
• Device Model Number: 416718
• Device Lot Number: 5C03907
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• 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: 52 YR
• Patient Sex: Male