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U.S. Department of Health and Human Services

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

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CONVATEC DOMINICAN REPUBLIC INC NATURA + POUCH, COLOSTOMY Back to Search Results
Model Number 416416
Device Problems Break (1069); Burst Container or Vessel (1074)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
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. Mdr 9618003-2019-05608 / device 1 of 1. (b)(4).
 
Event Description
The mother reports that ¿the top seam broke open, spilling fecal material onto the end user¿s central line. ¿ it was reported by the mother that on the night of the event when she checked on the child at ¿9 o¿clock her bag was not full, at 10 o¿clock there was poop everywhere¿, ¿all over her chest, her arms, in her actual central lines. " per the mother, the pouches are coming apart at the top and the side of the pouch and was previously reported. The mother states that the patient has ¿short bowl syndrome, so her stools are very watery". The mother was questioned on how the stool could have entered the central lines, per her report ¿she was receiving her infusion¿. The dressing gets changed ¿every 7 days,¿ it is unknown when the last dressing was applied. The dressing applied to the central line is a ¿standard central line dressing that is clear¿. When she noted the stool on the patient, her central line dressing was ¿soiled, the lines were soiled; the stool was under the dressing and in the lines". The mother states stool "must have entered where the iv lines connect to the central lines, since she was getting an infusion at the time". The child was then taken to the emergency room where blood cultures were obtained ¿one peripheral and one from the central line¿. The central line was in the child¿s ¿right upper chest¿. She reports that they were sent home but called back to the hospital today because the blood cultures were positive. The preliminary results reported grew both ¿gram negative and gram positive cocci¿. Once the final results had been released from the laboratory, it was requested the final culture result organism be obtained by the mother and reported. She could only report that ¿the doctor told me is that it is fecal matter growing¿. At the time of the report, the mother stated the child was ¿currently in icu, she has a pretty bad infection. ¿ the initial course of treatment was reported to be ¿vancomycin, rocephin, and flagyl¿, but had been changed once the final culture results were received to a medication unknown. Per the mother, the patient is stable and would be in the children¿s hospital for ¿14 days with this new antibiotic¿. While in the hospital, the child had to be taken to ¿surgery for a new central line¿ due to the contamination of the line from the event.
 
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Brand NameNATURA +
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer Contact
pamela meadows
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9221194
MDR Text Key163301457
Report Number9618003-2019-05608
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,other
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number416416
Device Lot Number9G03059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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