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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Device Handling Problem (3265)
Patient Problems Erythema (1840); Itching Sensation (1943); Fungal Infection (2419); Tissue Breakdown (2681); Blister (4537)
Event Type  Injury  
Event Description
The end user provided very limited information and reported that this was an ongoing issue for years and could not provide date of onset. She also stated that she was a multi-product user as she had a known diagnosed allergy to adhesives and did not get good results with non-adhesive system. She now discontinued the use of company's product and alternated with other manufacturers which seemed to keep her skin in check. However, when she did not rotate, her skin appeared red with blisters, weeping, itching and a fungal overgrowth for which she required antibiotics and anti-fungal. She also stated that this had occurred under both the mass and tape collar on the product. She declined to provide additional information such as the name of the medications, the time when she needed a medication for use of the convatec product and declined to provide the photos also.
 
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Brand NameL3O0100 - ACTIVE LIFE
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 Key13868597
MDR Text Key287827836
Report Number9618003-2022-00260
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
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 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number022771
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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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