MAUDE Adverse Event Report: UNOMEDICAL S.R.O. ESTEEM CLOSED POUCH, 60/70MM, 2 2/5 BY 2 3/4; POUCH, COLOSTOMY

Model Number 420507

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

Date of mfr: 07/2015.Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

An end user reported the traumatic removal of the device due to excessive adhesive.

Manufacturer Narrative

No sample was received, therefore detailed tests and evaluation cannot be performed.Production journal and job ticket were checked and no special records were found.The result of device history records showed that all relevant tests required during the manufacturing process and the final product releasing were carried out and met the requirements.Based on the information received and investigation results the root cause of the failure cannot be determined.No corrective actions are recommended at this time.No previous investigations are available.After review of the returned product (if available) and 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 action 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 CLOSED POUCH, 60/70MM, 2 2/5 BY 2 3/4
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce, 07101 ; LO 07101
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5444853
• MDR Text Key: 38479239
• Report Number: 3005778470-2016-00001
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Model Number: 420507
• Device Lot Number: 208133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2016
• 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