MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0215 - NATURA+ POUCH, COLOSTOMY

Model Number 416418

Device Problems Fluid Leak (1250); Malposition of Device (2616)

Patient Problem Distress (2329)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).

Event Description

The end user reported that five wafers with moldable starter hole was off centered which contributed to undermining of wafer with stool within less than one to two days wear time, therefore, required removal and replacement of device. The end user reported typical wear time of six to seven days. She also explained the skin care preparation prior to wafer application by cleansing with warm water, pat dried and then, eakin cohesive seal was applied after molding to fit to the back of the wafer aligning with stoma opening in order apply the wafer and secure the pouch. Consumer declined the use of additional accessories such as wipes or pastes due to skin sensitivities to alcohol content. Consumer reported that pouch was worn with a slight angle towards left side, denied the use of ostomy standard belt, hernia belt or wrap; emptied the pouch when one-third to half was full and reported typical liquid output. No photo is available at this time. There was no physical harm experienced by customer, but embarrassment was reported from wafer leakage and an associated odor.

• Brand Name: L3O0215 - NATURA+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14514111
• MDR Text Key: 292740022
• Report Number: 9618003-2022-00565
• 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

• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 416418
• Device Lot Number: 1E00669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown