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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA POUCH, COLOSTOMY Back to Search Results
Model Number 401502
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative
Mdr 9618003-2021-02655 / device 2 of 2. (b)(6). Based on the available information, this event is deemed to be a serious injury. 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 she developed urinary tract infection (uti). Laboratory tests showed e-coli in urine and was started on an unknown antibiotic. No photo available at this time.
 
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Brand NameL3O0200 - 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 Key12771669
MDR Text Key280942869
Report Number9618003-2021-02655
Device Sequence Number1
Product Code EZQ
UDI-Device Identifier00768455182411
UDI-Public00768455182411
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 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date08/08/2022
Device Model Number401502
Device Lot Number7H00390
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/09/2017
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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