MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; BAG, URINARY, ILEOSTOMY

Model Number	175793
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Chills (2191); Diaphoresis (2452)
Date of Event	01/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by healthcare professional nurse that end user had been using this product from almost twenty two years with usual wear-time of five days.On (b)(6) 2022, he reported about an appliance that he had for approximately three years.Consumer stated that he developed a urinary tract infection several hours after using the appliance.He reported there was nothing different or unusual about the product's appearance.He experienced chills, sweats, and dark concentrated urine (no odor).Consumer suspected that it was due to the product since he had it on hand for about three years.He also reported that the appliance was stored in a dry place.He saw his urologist past week who prescribed him ciprofloxacin for his urinary tract infection.Consumer felt that the appliance might have caused the infection, but the doctor did not confirm.Consumer experienced chronic urinary tract infection which he stated were becoming more frequent.There was no cause determined by his doctor, but he followed up again with urologist who did not determine an exact cause of his current urinary tract infection.The urologist did not confirm that pouch caused the infection.He had a history of frequent urinary tract infection, sometimes every two weeks.His urologist suggested him to replace the pouch twice weekly instead of every five days.He advised him to empty pouch when one-third full and also to wash hands prior to performing ostomy care.The consumer had been following recommendations.Currently he was not taking any antibiotics.He is now feeling better and no longer reporting fever, chills, or concentrated urine.No photo is available at this time.

• Brand Name: L3O0100 - ACTIVE LIFE
• 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: 13633945
• Report Number: 9618003-2022-00235
• Device Sequence Number: 5201799
• Product Code: EXH
• UDI-Device Identifier: 00768455181353
• UDI-Public: 00768455181353
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 175793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 03/01/2022
• 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 Age: 81
• Patient Sex: Male