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

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.

• 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 Key: 13926350
• MDR Text Key: 288045127
• Report Number: 9618003-2022-00255
• Device Sequence Number: 1
• Product Code: EXH
• UDI-Device Identifier: 00768455182787
• UDI-Public: 00768455182787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 401544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male