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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
Device 5 of 5. Contact office address: (b)(4). 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. (b)(4).
 
Event Description
The end user reported an ongoing issue with unknown number of clips from an unknown number of boxes. She suspects that it is a total of 5 clips. She had leakage from tail closure of pouch when it the clip cracked which caused a urinary tract infection (uti) and she had to take antibiotics due to uti. The laboratory result showed e-coli in the urine and was started on an unknown antibiotic. At the time of this report the patient continued using the product. The product was used by end user and 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 Key12771607
MDR Text Key280469603
Report Number9618003-2021-02654
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
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 Model Number401502
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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