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

Model Number	401544
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Erythema (1840); Peeling (1999); Burning Sensation (2146)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 9618003-2022-00255
• Device Sequence Number: 12351500
• Product Code: EXH
• UDI-Device Identifier: 00768455182787
• UDI-Public: 00768455182787
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 401544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male