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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; BAG, URINARY, ILEOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; BAG, URINARY, ILEOSTOMY Back to Search Results
Model Number 401544
Device Problem Sharp Edges (4013)
Patient Problems Erythema (1840); Peeling (1999); Burning Sensation (2146)
Event Type  malfunction  
Event Description
The end user¿s wife who is also the caregiver reported that after she had applied the two-piece urostomy pouch, the end user thought that the edge of the pouch was hitting his skin, which felt rough from one pouch out of sample pack of three pouches.She stated that after a few hours of wear, the skin under the white mesh on the body side of the pouch looked irritated slightly.It did not appear like an actual allergic reaction but just where the pouch touched exposed skin like on the bottom part of the abdomen down to his thigh was red in color and the end user complained of sensitivity almost like a mild sunburn.She removed wafer and pouch and then applied the one-piece urostomy pouch and then immediately the end user said that he was much better and more comfortable.The product was used.No photo is available at this time.
 
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Brand Name
L3O0200 - NATURA
Type of Device
BAG, URINARY, ILEOSTOMY
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 Key13926350
MDR Text Key288045127
Report Number9618003-2022-00255
Device Sequence Number1
Product Code EXH
UDI-Device Identifier00768455182787
UDI-Public00768455182787
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 Other
Reporter Occupation Other
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number401544
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/03/2022
Initial Date FDA Received03/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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