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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 416416
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278); Reaction (2414)
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
The end user called to rule out the possible cause of an all over body rash she had been experiencing for the past 3 weeks. She had hives with itching from the tip of her head to the soles of her feet. Reportedly, she had seen a dermatologist twice, and said the health care professional was trying to determine the cause of the hives. She had used the convatec product for 4 years, and her usual wear time was 3-4 days. The only accessory she occasionally used was medline remedy phytoplex powder. The dermatologist gave her a steroid shot, but she got worse and not better. The cause of the skin reaction was unknown and the rash persisted. The end user continued to use the product. No photo is available at this time.
 
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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
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 Key10934072
MDR Text Key219131879
Report Number9618003-2020-15382
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number416416
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? No
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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