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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 401512
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Fungal Infection (2419)
Event Date 02/06/2019
Event Type  Injury  
Manufacturer Narrative
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
It was reported that about 12 months ago, the end user developed a red, itchy rash under the outer edge of the tape collar and on her abdomen where the pouch comfort panel is in contact with her skin. The symptoms started as a moist red rash, then became runny with a strong odor. It eventually dried up and skin became flaky. The cycle then started again. She saw her primary care doctor several months ago, who diagnosed her with a fungal rash and prescribed oral diflucan, and topical nystatin cream. She took several rounds of the diflucan and had been using the nystatin for months with no change in symptoms. She then recently saw a nurse who recommended nystatin powder instead. So, she has been applying the powder topically for the past several weeks. Her skin care routine is to clean with either dial soap, perineal cleanser or plain water, then apply 3 layers of nystatin with a barrier wipe over each layer. She reported that her symptoms have not responded with this treatment either. She then recently tried using dry gauze under the outer edges of the tape collar and under her pouch to keep the pouch material off her skin. She thought her symptoms improved slightly when she used the gauze. No photo is available at this time.
 
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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
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9756038
MDR Text Key183097151
Report Number9618003-2020-03470
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,health professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number401512
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/06/2020
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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