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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 401527
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
Event Type  Injury  
Manufacturer Narrative
Contact office address: (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. Fda registration number: reporting site: (b)(4), manufacturing site: (b)(4).
 
Event Description
The end user reported that she had used this product with no issues until this box and she noted that she developed itching under the pouch material that had progressed into a red rash and now was over her entire body. She believed it was more of an allergy. However, the end user reported no known allergies. She also reported that she went to her doctor who did not order any medication and advised her to find another product. The end user was offered various samples as an alternative, but consumer did not want to trial any other product. She mentioned that she did not experience leakage. She reported that when she applied a piece of material in between her pouch and her skin, the rash and itchy began to subside. The end user continued to use soft cotton material to separate pouch from touching skin since that worked well. She was also using over the counter zinc oxide 25% protectant spray to affected area and noted improvement. Reportedly, the patient continued using the product. No photo is 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 Key12473849
MDR Text Key271453154
Report Number9618003-2021-02035
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number401527
Device Lot Number1A02143
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 Manufactured01/15/2021
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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