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U.S. Department of Health and Human Services

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

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CONVATEC DOMINICAN REPUBLIC INC L3O0215 - NATURA+ POUCH, COLOSTOMY Back to Search Results
Model Number 416418
Device Problems Fluid Leak (1250); Malposition of Device (2616)
Patient Problem Distress (2329)
Event Type  malfunction  
Manufacturer Narrative
Device 2 of 5. 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.
 
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Brand NameL3O0215 - NATURA+
Type of DevicePOUCH, 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 Key14513823
MDR Text Key292717592
Report Number9618003-2022-00563
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number416418
Device Lot Number1E00669
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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