MAUDE Adverse Event Report: UNOMEDICAL S.R.O. ESTEEM® + ONE-PIECE CUT-TO-FIT CLOSED-END POUCH; POUCH, COLOSTOMY

Model Number 416701

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

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 reported to the fda on november 18, 2015.(b)(4).

Event Description

The end user reported the new one-piece pouch had excessive adhesive which made it very difficult to remove without stripping the skin.No further patient complications were reported as a result of this event.

Manufacturer Narrative

No samples associated with this complaint were received.No previous investigations are available.A batch review was conducted and no discrepancies or non-conformance related to complaint issue was observed during manufacturing process.All relevant tests required during manufacturing process and the final product release were performed and met test requirements.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.Device manufacture date - 04/2015.Could not be entered into esubmitter with only month and year.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® + ONE-PIECE CUT-TO-FIT CLOSED-END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5233181
• MDR Text Key: 31505267
• Report Number: 3005778470-2015-00037
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Model Number: 416701
• Device Lot Number: 193558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1