MAUDE Adverse Event Report: UNOMEDICAL S.R.O. L3O0215 - NATURA+; POUCH, COLOSTOMY

Model Number 421681

Device Problem Insufficient Information (3190)

Patient Problems Granuloma (1876); Pain (1994)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

After complaint and clinical escalation review, this emdr is being submitted due to the reported hpergranulation related to pouch film.Based on the details, it is unclear if the pouch film would cause the hypergranulation, as it remains unclear the link between the pouch film and hypergrnulation.Per clinical review, the use of other potential products may contribute to the cause or pre-existing conditions.Although the product causality link has not been established or found in similar complaints, the emdr is proactively being submitted for awareness.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: (b)(4), manufacturing site: (b)(4).

Event Description

The end user reported that the new lining of the pouches caused the skin to perspire, and when sweat got trapped under flanges, it causes hypergranulation.He also reported that he had a spot of hypergranulated skin against his stoma that had been cauterized six times since december of 2021.This procedure was expensive and painful.The product was used.Photographs depicting the issue were received from the complainant.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

This emdr is being submitted to include the further information in b5- describe event of problem.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 9618003.

• Brand Name: L3O0215 - NATURA+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14787313
• MDR Text Key: 294580177
• Report Number: 3005778470-2022-00046
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male